FDA Orange Book · active-ingredient family
Propranolol hydrochloride
Propranolol hydrochloride: 6 brands, 123 generics; first approved Oct 18, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 123 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
6
Generics (ANDA)
123
Listed patents
2
Next patent expiry
Oct 16, 2028
in 2 yr 3 mo
Brand (NDA) products
Originator applications
- ETONNDA 2054102014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4.28MG/ML SOLUTION ORAL Rx — - INNOPRAN XLRLDANI PHARMSNDA 02143820032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG CAPSULE, EXTENDED RELEASE ORAL Rx BX 120MG CAPSULE, EXTENDED RELEASE ORAL Rx BX - INDERAL LARLDANI PHARMSNDA 01855319874 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 160MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - PROPRANOLOL HYDROCHLORIDERLDBAXTER HLTHCARE CORPNDA 016419—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - INDERALRLDWYETH PHARMSNDA 016418—6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 90MG TABLET ORAL Discontinued — - WYETH AYERSTNDA 0195361986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SUSPENSION ORAL Discontinued —
Generic (ANDA) products (123)
Abbreviated applications
- PROPRANOLOL HYDROCHLORIDEMICRO LABSANDA 21723820264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 160MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEPAI HOLDINGSANDA 2191652026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/5ML SOLUTION ORAL Rx AA - PROPRANOLOL HYDROCHLORIDEIPCA LABS LTDANDA 20310320264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 160MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEMANKIND PHARMAANDA 21666320265 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PROPRANOLOL HYDROCHLORIDELUPINANDA 20434920244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 80MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 160MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEAMTAANDA 21202620204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 160MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 07017820182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Rx AB 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEADARE PHARMS INCANDA 07870320114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 160MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEZYDUS PHARMS USA INCANDA 09032120114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 160MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEUPSHER SMITH LABSANDA 07831120094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 80MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 160MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEIPCA LABS LTDANDA 07895520085 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PROPRANOLOL HYDROCHLORIDERSHIKMA FARMACEUTICAANDA 0777602008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - PROPRANOLOL HYDROCHLORIDENORTHSTAR HLTHCAREANDA 07821320085 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEACTAVIS ELIZABETHANDA 07849420074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 160MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 07802220074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 80MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 160MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEANDA REPOSITORYANDA 07806520074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 80MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 120MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 160MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEALLIEDANDA 0764002003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - PROPRANOLOL HYDROCHLORIDEFRESENIUS KABI USAANDA 0758262001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - PROPRANOLOL HYDROCHLORIDECHARTWELL INJECTABLEANDA 0757922000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - PROPRANOLOL HYDROCHLORIDEMYLANANDA 0722751989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEINWOOD LABSANDA 0724991989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEINWOOD LABSANDA 0725001989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEINWOOD LABSANDA 0725011989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEINWOOD LABSANDA 0725021989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 160MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEPAI HOLDINGS PHARMANDA 0719841989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/5ML SOLUTION ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEPAI HOLDINGS PHARMANDA 0719851989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML SOLUTION ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 0720631988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 0720661988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 0720671988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 0720681988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 0720691988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESANDOZANDA 0716581988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESANDOZANDA 0716871988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESANDOZANDA 0716881988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESANDOZANDA 0721971988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESANDOZANDA 0716891988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESANDOZANDA 0721981988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDELEDERLEANDA 0721171988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDELEDERLEANDA 0721181988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDELEDERLEANDA 0721191988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDELEDERLEANDA 0721201988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESUPERPHARMANDA 0715151988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESUPERPHARMANDA 0715161988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESUPERPHARMANDA 0715171988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESUPERPHARMANDA 0715181988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEANI PHARMSANDA 0719771988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEIMPAX LABS INCANDA 07197219883 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 0714951987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 0714961987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDETEVAANDA 0702321987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEANI PHARMSANDA 0717911987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0717921987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — - ROXANEANDA 0713881987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/ML CONCENTRATE ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDERSHIKMAANDA 07069019872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML SOLUTION ORAL Rx — 20MG/5ML SOLUTION ORAL Rx AA - PROPRANOLOL HYDROCHLORIDEINTERPHARMANDA 0713681987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEINTERPHARMANDA 0713691987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEINTERPHARMANDA 0713701987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEINTERPHARMANDA 0713711987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0703781987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0703791987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0703801987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0703811987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0703821987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0701431987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEPUREPAC PHARMANDA 0708141986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEPUREPAC PHARMANDA 0708151986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEPUREPAC PHARMANDA 0708161986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEPUREPAC PHARMANDA 0708171986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEPUREPAC PHARMANDA 0707571986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESCHERINGANDA 0701231986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEAIPING PHARM INCANDA 0712881986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 0706661986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0710981986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0711831986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 0703091986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 0713271986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEROXANEANDA 0705191986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEROXANEANDA 0705211986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWARNER CHILCOTTANDA 0704411986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWARNER CHILCOTTANDA 0704381986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWARNER CHILCOTTANDA 0704391986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWARNER CHILCOTTANDA 0704401986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWARNER CHILCOTTANDA 0704421986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEPH HEALTHANDA 07022119865 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0705511986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABS TEVAANDA 0705481986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEROXANEANDA 0705161986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEROXANEANDA 0705171986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEROXANEANDA 0705181986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEROXANEANDA 0705201986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDETEVAANDA 0702331986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDETEVAANDA 0702341986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 0706631986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 0706641986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 0706651986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 0706671986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEIMPAX LABS INCANDA 07197619862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0701751986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0701761986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0701771986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB - PROPRANOLOL HYDROCHLORIDESMITH AND NEPHEWANDA 0701351986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - PROPRANOLOL HYDROCHLORIDESMITH AND NEPHEWANDA 0701371986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - PROPRANOLOL HYDROCHLORIDESOLOPAKANDA 0701361986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABS TEVAANDA 0705491986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABS TEVAANDA 0705501986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEMYLANANDA 07021319855 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEINNOGENIXANDA 07032219855 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 0703061985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 0703071985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 0703081985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 0703101985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESCHERINGANDA 0701201985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESCHERINGANDA 0701211985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESCHERINGANDA 0701221985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDESCHERINGANDA 0701241985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 0701251985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 0701261985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 0701271985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 0701281985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0701401985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0701411985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0701421985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 0701441985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8338489 | in 2 yr 3 mo | U-1496 | |
| 8987262 | in 2 yr 3 mo | U-1988 |
Approval history
FDA approval span
First approval
44 yr 5 mo ago
Most recent approval
1 mo ago
Approvals span 1982–2026 across 129 FDA applications.
Brand (NDA) 65%
Generic (ANDA) 12395%
Propranolol hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
