Assyro AI

FDA Orange Book · active-ingredient family

Propranolol hydrochloride

Propranolol hydrochloride is approved as 6 brand and 122 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HEMANGEOL · NDA 205410

6

Brand (NDA)

122

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, concentrate, injectable, solution, suspension, tablet

ProductApplicantApplicationTEApproved
HEMANGEOLRLDETONNDA 205410—Mar 14, 2014
INNOPRAN XLRLD×2ANI PHARMSNDA 021438BXMar 12, 2003
INDERAL LARLD×4ANI PHARMSNDA 018553ABMar 18, 1987
PROPRANOLOL HYDROCHLORIDERLDBAXTER HLTHCARE CORPNDA 016419—Approved Prior to Jan 1, 1982
INDERALRLD×6WYETH PHARMSNDA 016418—Approved Prior to Jan 1, 1982
INDERALWYETH AYERSTNDA 019536—Dec 12, 1986

Generic (ANDA) products (122)

ProductApplicantApplicationTEApproved
PROPRANOLOL HYDROCHLORIDEPAI HOLDINGSANDA 219165AAJun 10, 2026
PROPRANOLOL HYDROCHLORIDE×4IPCA LABS LTDANDA 203103ABMay 01, 2026
PROPRANOLOL HYDROCHLORIDE×5MANKIND PHARMAANDA 216663ABJan 27, 2026
PROPRANOLOL HYDROCHLORIDE×4LUPINANDA 204349—Jan 12, 2024
PROPRANOLOL HYDROCHLORIDE×4AMTAANDA 212026ABJan 06, 2020
PROPRANOLOL HYDROCHLORIDE×2WATSON LABSANDA 070178—Apr 23, 2018
PROPRANOLOL HYDROCHLORIDE×4ADARE PHARMS INCANDA 078703ABJul 15, 2011
PROPRANOLOL HYDROCHLORIDE×4ZYDUS PHARMS USA INCANDA 090321ABMar 25, 2011
PROPRANOLOL HYDROCHLORIDE×4UPSHER SMITH LABSANDA 078311—Mar 06, 2009
PROPRANOLOL HYDROCHLORIDE×5IPCA LABS LTDANDA 078955ABJun 02, 2008
PROPRANOLOL HYDROCHLORIDEHIKMA FARMACEUTICAANDA 077760APJan 31, 2008
PROPRANOLOL HYDROCHLORIDE×5NORTHSTAR HLTHCAREANDA 078213—Jan 10, 2008
PROPRANOLOL HYDROCHLORIDE×4ACTAVIS ELIZABETHANDA 078494ABAug 10, 2007
PROPRANOLOL HYDROCHLORIDE×4CHARTWELL RXANDA 078022—Feb 15, 2007
PROPRANOLOL HYDROCHLORIDE×4ANDA REPOSITORYANDA 078065ABJan 26, 2007
PROPRANOLOL HYDROCHLORIDEALLIEDANDA 076400—Feb 26, 2003
PROPRANOLOL HYDROCHLORIDEFRESENIUS KABI USAANDA 075826APAug 31, 2001
PROPRANOLOL HYDROCHLORIDECHARTWELL INJECTABLEANDA 075792—Aug 29, 2000
PROPRANOLOL HYDROCHLORIDEMYLANANDA 072275—Jun 09, 1989
PROPRANOLOL HYDROCHLORIDEINWOOD LABSANDA 072499—Apr 11, 1989
PROPRANOLOL HYDROCHLORIDEINWOOD LABSANDA 072500—Apr 11, 1989
PROPRANOLOL HYDROCHLORIDEINWOOD LABSANDA 072501—Apr 11, 1989
PROPRANOLOL HYDROCHLORIDEINWOOD LABSANDA 072502—Apr 11, 1989
PROPRANOLOL HYDROCHLORIDEPAI HOLDINGS PHARMANDA 071984—Mar 03, 1989
PROPRANOLOL HYDROCHLORIDEPAI HOLDINGS PHARMANDA 071985—Mar 03, 1989
PROPRANOLOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 072063—Jul 29, 1988
PROPRANOLOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 072066—Jul 29, 1988
PROPRANOLOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 072067—Jul 29, 1988
PROPRANOLOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 072068—Jul 29, 1988
PROPRANOLOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 072069—Jul 29, 1988
PROPRANOLOL HYDROCHLORIDESANDOZANDA 071658—Jul 05, 1988
PROPRANOLOL HYDROCHLORIDESANDOZANDA 071687—Jul 05, 1988
PROPRANOLOL HYDROCHLORIDESANDOZANDA 071688—Jul 05, 1988
PROPRANOLOL HYDROCHLORIDESANDOZANDA 072197—Jul 05, 1988
PROPRANOLOL HYDROCHLORIDESANDOZANDA 071689—Jul 05, 1988
PROPRANOLOL HYDROCHLORIDESANDOZANDA 072198—Jul 05, 1988
PROPRANOLOL HYDROCHLORIDELEDERLEANDA 072117—Jun 23, 1988
PROPRANOLOL HYDROCHLORIDELEDERLEANDA 072118—Jun 23, 1988
PROPRANOLOL HYDROCHLORIDELEDERLEANDA 072119—Jun 23, 1988
PROPRANOLOL HYDROCHLORIDELEDERLEANDA 072120—Jun 23, 1988
PROPRANOLOL HYDROCHLORIDESUPERPHARMANDA 071515—Jun 08, 1988
PROPRANOLOL HYDROCHLORIDESUPERPHARMANDA 071516—Jun 08, 1988
PROPRANOLOL HYDROCHLORIDESUPERPHARMANDA 071517—Jun 08, 1988
PROPRANOLOL HYDROCHLORIDESUPERPHARMANDA 071518—Jun 08, 1988
PROPRANOLOL HYDROCHLORIDEANI PHARMSANDA 071977—Apr 06, 1988
PROPRANOLOL HYDROCHLORIDE×3IMPAX LABS INCANDA 071972ABApr 06, 1988
PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 071495—Dec 31, 1987
PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 071496—Dec 31, 1987
PROPRANOLOL HYDROCHLORIDETEVAANDA 070232—Oct 07, 1987
PROPRANOLOL HYDROCHLORIDEANI PHARMSANDA 071791—Jul 15, 1987
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 071792—Jul 15, 1987
PROPRANOLOL HYDROCHLORIDE INTENSOLROXANEANDA 071388—May 15, 1987
PROPRANOLOL HYDROCHLORIDE×2HIKMAANDA 070690AAMay 15, 1987
PROPRANOLOL HYDROCHLORIDEINTERPHARMANDA 071368—May 05, 1987
PROPRANOLOL HYDROCHLORIDEINTERPHARMANDA 071369—May 05, 1987
PROPRANOLOL HYDROCHLORIDEINTERPHARMANDA 071370—May 05, 1987
PROPRANOLOL HYDROCHLORIDEINTERPHARMANDA 071371—May 05, 1987
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070378—Mar 19, 1987
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070379—Mar 19, 1987
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070380—Mar 19, 1987
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070381—Mar 19, 1987
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070382—Mar 19, 1987
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070143—Jan 15, 1987
PROPRANOLOL HYDROCHLORIDEPUREPAC PHARMANDA 070814—Nov 03, 1986
PROPRANOLOL HYDROCHLORIDEPUREPAC PHARMANDA 070815—Nov 03, 1986
PROPRANOLOL HYDROCHLORIDEPUREPAC PHARMANDA 070816—Nov 03, 1986
PROPRANOLOL HYDROCHLORIDEPUREPAC PHARMANDA 070817—Nov 03, 1986
PROPRANOLOL HYDROCHLORIDEPUREPAC PHARMANDA 070757—Nov 03, 1986
PROPRANOLOL HYDROCHLORIDESCHERINGANDA 070123—Oct 29, 1986
PROPRANOLOL HYDROCHLORIDEAIPING PHARM INCANDA 071288—Oct 22, 1986
PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 070666—Oct 10, 1986
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 071098—Oct 06, 1986
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 071183—Oct 06, 1986
PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 070309—Oct 01, 1986
PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 071327—Oct 01, 1986
PROPRANOLOL HYDROCHLORIDEROXANEANDA 070519—Sep 24, 1986
PROPRANOLOL HYDROCHLORIDEROXANEANDA 070521—Sep 24, 1986
PROPRANOLOL HYDROCHLORIDEWARNER CHILCOTTANDA 070441—Sep 24, 1986
PROPRANOLOL HYDROCHLORIDEWARNER CHILCOTTANDA 070438—Sep 15, 1986
PROPRANOLOL HYDROCHLORIDEWARNER CHILCOTTANDA 070439—Sep 15, 1986
PROPRANOLOL HYDROCHLORIDEWARNER CHILCOTTANDA 070440—Sep 15, 1986
PROPRANOLOL HYDROCHLORIDEWARNER CHILCOTTANDA 070442—Sep 15, 1986
PROPRANOLOL HYDROCHLORIDE×5PH HEALTHANDA 070221ABAug 01, 1986
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070551—Jul 10, 1986
PROPRANOLOL HYDROCHLORIDEWATSON LABS TEVAANDA 070548—Jul 10, 1986
PROPRANOLOL HYDROCHLORIDEROXANEANDA 070516—Jul 07, 1986
PROPRANOLOL HYDROCHLORIDEROXANEANDA 070517—Jul 07, 1986
PROPRANOLOL HYDROCHLORIDEROXANEANDA 070518—Jul 07, 1986
PROPRANOLOL HYDROCHLORIDEROXANEANDA 070520—Jul 07, 1986
PROPRANOLOL HYDROCHLORIDETEVAANDA 070233—Jun 23, 1986
PROPRANOLOL HYDROCHLORIDETEVAANDA 070234—Jun 23, 1986
PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 070663—Jun 13, 1986
PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 070664—Jun 13, 1986
PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 070665—Jun 13, 1986
PROPRANOLOL HYDROCHLORIDECHARTWELL RXANDA 070667—Jun 13, 1986
PROPRANOLOL HYDROCHLORIDE×2IMPAX LABS INCANDA 071976ABMay 13, 1986
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070175ABMay 13, 1986
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070176ABMay 13, 1986
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070177ABMay 13, 1986
PROPRANOLOL HYDROCHLORIDESMITH AND NEPHEWANDA 070135—Apr 15, 1986
PROPRANOLOL HYDROCHLORIDESMITH AND NEPHEWANDA 070137—Apr 15, 1986
PROPRANOLOL HYDROCHLORIDESOLOPAKANDA 070136—Apr 15, 1986
PROPRANOLOL HYDROCHLORIDEWATSON LABS TEVAANDA 070549—Apr 11, 1986
PROPRANOLOL HYDROCHLORIDEWATSON LABS TEVAANDA 070550—Apr 11, 1986
PROPRANOLOL HYDROCHLORIDE×5MYLANANDA 070213ABNov 19, 1985
PROPRANOLOL HYDROCHLORIDE×5INNOGENIXANDA 070322ABOct 22, 1985
PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 070306—Sep 09, 1985
PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 070307—Sep 09, 1985
PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 070308—Sep 09, 1985
PROPRANOLOL HYDROCHLORIDEDURAMED PHARMS BARRANDA 070310—Sep 09, 1985
PROPRANOLOL HYDROCHLORIDESCHERINGANDA 070120—Aug 06, 1985
PROPRANOLOL HYDROCHLORIDESCHERINGANDA 070121—Aug 06, 1985
PROPRANOLOL HYDROCHLORIDESCHERINGANDA 070122—Aug 06, 1985
PROPRANOLOL HYDROCHLORIDESCHERINGANDA 070124—Aug 06, 1985
PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 070125—Jul 30, 1985
PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 070126—Jul 30, 1985
PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 070127—Jul 30, 1985
PROPRANOLOL HYDROCHLORIDEDAVA PHARMS INCANDA 070128—Jul 30, 1985
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070140—Jul 30, 1985
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070141—Jul 30, 1985
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070142—Jul 30, 1985
PROPRANOLOL HYDROCHLORIDEWATSON LABSANDA 070144—Jul 30, 1985

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

Propranolol hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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