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FDA Orange Book · active-ingredient family

Propranolol hydrochloride

Propranolol hydrochloride: 6 brands, 122 generics; first approved Oct 18, 1982; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available — 122 ANDA applications approved.

Earliest patent expiry Oct 16, 2028
Brands (NDA)
6
Generics (ANDA)
122
Listed patents
2
Next patent expiry
Oct 16, 2028
in 2 yr 4 mo
Originator applications

Brand (NDA) products

NDA 2054102014
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
4.28MG/MLSOLUTIONORALRx
NDA 02143820032 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGCAPSULE, EXTENDED RELEASEORALRxBX
120MGCAPSULE, EXTENDED RELEASEORALRxBX
NDA 01855319874 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
160MGCAPSULE, EXTENDED RELEASEORALRxAB
80MGCAPSULE, EXTENDED RELEASEORALRxAB
120MGCAPSULE, EXTENDED RELEASEORALRxAB
60MGCAPSULE, EXTENDED RELEASEORALRxAB
NDA 016419
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLEINJECTIONDiscontinued
NDA 0164186 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLETORALDiscontinued
NDA 0195361986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MG/MLSUSPENSIONORALDiscontinued
Abbreviated applications

Generic (ANDA) products (122)

ANDA 2191652026
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG/5MLSOLUTIONORALRxAA
ANDA 20310320264 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGCAPSULE, EXTENDED RELEASEORALRxAB
80MGCAPSULE, EXTENDED RELEASEORALRxAB
120MGCAPSULE, EXTENDED RELEASEORALRxAB
160MGCAPSULE, EXTENDED RELEASEORALRxAB
ANDA 21666320265 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALRxAB
20MGTABLETORALRxAB
40MGTABLETORALRxAB
60MGTABLETORALRxAB
80MGTABLETORALRxAB
ANDA 20434920244 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGCAPSULE, EXTENDED RELEASEORALDiscontinued
80MGCAPSULE, EXTENDED RELEASEORALDiscontinued
120MGCAPSULE, EXTENDED RELEASEORALDiscontinued
160MGCAPSULE, EXTENDED RELEASEORALDiscontinued
ANDA 21202620204 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGCAPSULE, EXTENDED RELEASEORALRxAB
80MGCAPSULE, EXTENDED RELEASEORALRxAB
120MGCAPSULE, EXTENDED RELEASEORALRxAB
160MGCAPSULE, EXTENDED RELEASEORALRxAB
ANDA 07017820182 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALRxAB
60MGTABLETORALDiscontinued
ANDA 07870320114 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGCAPSULE, EXTENDED RELEASEORALRxAB
80MGCAPSULE, EXTENDED RELEASEORALRxAB
120MGCAPSULE, EXTENDED RELEASEORALRxAB
160MGCAPSULE, EXTENDED RELEASEORALRxAB
ANDA 09032120114 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGCAPSULE, EXTENDED RELEASEORALRxAB
80MGCAPSULE, EXTENDED RELEASEORALRxAB
120MGCAPSULE, EXTENDED RELEASEORALRxAB
160MGCAPSULE, EXTENDED RELEASEORALRxAB
ANDA 07831120094 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGCAPSULE, EXTENDED RELEASEORALDiscontinued
80MGCAPSULE, EXTENDED RELEASEORALDiscontinued
120MGCAPSULE, EXTENDED RELEASEORALDiscontinued
160MGCAPSULE, EXTENDED RELEASEORALDiscontinued
ANDA 07895520085 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALRxAB
20MGTABLETORALRxAB
40MGTABLETORALRxAB
60MGTABLETORALRxAB
80MGTABLETORALRxAB
ANDA 0777602008
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MG/MLINJECTABLEINJECTIONRxAP
ANDA 07821320085 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
20MGTABLETORALDiscontinued
40MGTABLETORALDiscontinued
60MGTABLETORALDiscontinued
80MGTABLETORALDiscontinued
ANDA 07849420074 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGCAPSULE, EXTENDED RELEASEORALRxAB
80MGCAPSULE, EXTENDED RELEASEORALRxAB
120MGCAPSULE, EXTENDED RELEASEORALRxAB
160MGCAPSULE, EXTENDED RELEASEORALRxAB
ANDA 07802220074 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGCAPSULE, EXTENDED RELEASEORALDiscontinued
80MGCAPSULE, EXTENDED RELEASEORALDiscontinued
120MGCAPSULE, EXTENDED RELEASEORALDiscontinued
160MGCAPSULE, EXTENDED RELEASEORALDiscontinued
ANDA 07806520074 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGCAPSULE, EXTENDED RELEASEORALRxAB
80MGCAPSULE, EXTENDED RELEASEORALRxAB
120MGCAPSULE, EXTENDED RELEASEORALRxAB
160MGCAPSULE, EXTENDED RELEASEORALRxAB
ANDA 0764002003
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MG/MLINJECTABLEINJECTIONDiscontinued
ANDA 0758262001
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MG/MLINJECTABLEINJECTIONRxAP
ANDA 0757922000
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MG/MLINJECTABLEINJECTIONDiscontinued
ANDA 0722751989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0724991989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGCAPSULE, EXTENDED RELEASEORALDiscontinued
ANDA 0725001989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGCAPSULE, EXTENDED RELEASEORALDiscontinued
ANDA 0725011989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
120MGCAPSULE, EXTENDED RELEASEORALDiscontinued
ANDA 0725021989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
160MGCAPSULE, EXTENDED RELEASEORALDiscontinued
ANDA 0719841989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG/5MLSOLUTIONORALDiscontinued
ANDA 0719851989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MG/5MLSOLUTIONORALDiscontinued
ANDA 0720631988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0720661988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0720671988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0720681988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0720691988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0716581988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0716871988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0716881988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0721971988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0716891988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0721981988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
90MGTABLETORALDiscontinued
ANDA 0721171988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0721181988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0721191988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0721201988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0715151988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0715161988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0715171988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0715181988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0719771988
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
90MGTABLETORALDiscontinued
ANDA 07197219883 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALRxAB
20MGTABLETORALRxAB
40MGTABLETORALRxAB
ANDA 0714951987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0714961987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
90MGTABLETORALDiscontinued
ANDA 0702321987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0717911987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0717921987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
90MGTABLETORALDiscontinued
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MG/MLCONCENTRATEORALDiscontinued
ANDA 07069019872 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MG/5MLSOLUTIONORALRx
20MG/5MLSOLUTIONORALRxAA
ANDA 0713681987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0713691987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0713701987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0713711987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0703781987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0703791987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0703801987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0703811987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0703821987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0701431987
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0708141986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0708151986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0708161986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0708171986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0707571986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0701231986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0712881986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
90MGTABLETORALDiscontinued
ANDA 0706661986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0710981986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0711831986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
90MGTABLETORALDiscontinued
ANDA 0703091986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0713271986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
90MGTABLETORALDiscontinued
ANDA 0705191986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0705211986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
90MGTABLETORALDiscontinued
ANDA 0704411986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
60MGTABLETORALDiscontinued
ANDA 0704381986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0704391986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0704401986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0704421986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 07022119865 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALRxAB
10MGTABLETORALRxAB
20MGTABLETORALRxAB
40MGTABLETORALRxAB
60MGTABLETORALRxAB
ANDA 0705511986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0705481986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0705161986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0705171986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0705181986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0705201986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0702331986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0702341986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0706631986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0706641986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0706651986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0706671986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 07197619862 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALRxAB
60MGTABLETORALRxAB
ANDA 0701751986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALRxAB
ANDA 0701761986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALRxAB
ANDA 0701771986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALRxAB
ANDA 0701351986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MG/MLINJECTABLEINJECTIONDiscontinued
ANDA 0701371986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MG/MLINJECTABLEINJECTIONDiscontinued
ANDA 0701361986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1MG/MLINJECTABLEINJECTIONDiscontinued
ANDA 0705491986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0705501986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 07021319855 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALRxAB
10MGTABLETORALRxAB
20MGTABLETORALRxAB
80MGTABLETORALRxAB
60MGTABLETORALRxAB
ANDA 07032219855 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALRxAB
10MGTABLETORALRxAB
20MGTABLETORALRxAB
40MGTABLETORALRxAB
60MGTABLETORALRxAB
ANDA 0703061985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0703071985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0703081985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0703101985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0701201985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0701211985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0701221985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0701241985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0701251985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0701261985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0701271985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0701281985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
ANDA 0701401985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
10MGTABLETORALDiscontinued
ANDA 0701411985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MGTABLETORALDiscontinued
ANDA 0701421985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
40MGTABLETORALDiscontinued
ANDA 0701441985
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
80MGTABLETORALDiscontinued
Protection horizon

Patent & exclusivity timeline

2026202720282029TodayPatent 8338489 — 2028-10-16Patent 8338489Patent 8987262 — 2028-10-16Patent 8987262
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8338489Oct 16, 2028in 2 yr 4 mo
U-1496
8987262Oct 16, 2028in 2 yr 4 mo
U-1988
FDA approval span

Approval history

First approval
Oct 18, 1982
44 yr 4 mo ago
Most recent approval
Jun 10, 2026
1 mo ago

Approvals span 1982–2026 across 128 FDA applications.

Brand (NDA) 65%
Generic (ANDA) 12295%

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.

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