Assyro AI

FDA Orange Book · active-ingredient family

Albuterol sulfate

Albuterol sulfate is approved as 15 brand and 77 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PROAIR DIGIHALER · NDA 205636

15

Brand (NDA)

77

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, metered, capsule, powder, metered, solution, syrup, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
PROAIR DIGIHALERRLD×2TEVA BRANDED PHARMNDA 205636—Dec 21, 2018
PROAIR HFARLDTEVA BRANDED PHARMNDA 021457AB2Oct 29, 2004
ACCUNEBRLD×2PHARMOBEDIENTNDA 020949—Apr 30, 2001
VENTOLIN HFARLDGLAXOSMITHKLINENDA 020983AB3Apr 19, 2001
PROVENTIL-HFARLDKINDEVANDA 020503AB1Aug 15, 1996
VOLMAXRLD×2MURONDA 019604—Dec 23, 1992
VENTOLINRLDGLAXOSMITHKLINENDA 019773—Apr 23, 1992
PROVENTILRLD×2SCHERINGNDA 019243—Jan 14, 1987
PROVENTILRLDSCHERINGNDA 018062—Jan 19, 1983
PROVENTILRLD×2SCHERINGNDA 017853—May 07, 1982
VENTOLIN ROTACAPSGLAXOSMITHKLINENDA 019489—May 04, 1988
PROVENTILSCHERINGNDA 019383—Jul 13, 1987
VENTOLINGLAXOSMITHKLINENDA 019621—Jun 10, 1987
VENTOLINGLAXOSMITHKLINENDA 019269—Jan 16, 1987
VENTOLIN×2GLAXOSMITHKLINENDA 019112—Jul 10, 1986

Generic (ANDA) products (77)

ProductApplicantApplicationTEApproved
ALBUTEROL SULFATECIPLAANDA 219409AB3Apr 22, 2026
ALBUTEROL SULFATEAMNEAL IRELAND LTDANDA 211600AB2Dec 01, 2025
ALBUTEROL SULFATERITEDOSE CORPANDA 218386ANMar 12, 2025
ALBUTEROL SULFATEARMSTRONG PHARMSANDA 212447AB2May 21, 2024
ALBUTEROL SULFATE×2LEXENPHARMANDA 215571ANMay 03, 2024
ALBUTEROL SULFATE×2RITEDOSE CORPANDA 214531ANDec 28, 2021
ALBUTEROL SULFATESANDOZANDA 207085AB1Jun 01, 2021
ALBUTEROL SULFATE×2ZYDUS PHARMSANDA 208884ABOct 22, 2020
ALBUTEROL SULFATE×2HIBROW HLTHCAREANDA 213524—Oct 08, 2020
ALBUTEROL SULFATELUPINANDA 209954AB2Aug 24, 2020
ALBUTEROL SULFATE×2AUROBINDO PHARMA LTDANDA 213657—May 14, 2020
ALBUTEROL SULFATE×2LUOXIN AUROVITASANDA 211888ANApr 20, 2020
ALBUTEROL SULFATECIPLAANDA 209959AB1Apr 08, 2020
ALBUTEROL SULFATEPADAGIS USANDA 203760AB2Feb 24, 2020
ALBUTEROL SULFATEQUAGENANDA 212197AASep 06, 2019
ALBUTEROL SULFATE×2AIZANTANDA 210948BXMar 15, 2019
ALBUTEROL SULFATE×2ACERTIS PHARMSANDA 211397ABOct 26, 2018
ALBUTEROL SULFATE×2RISINGANDA 207046ABJun 29, 2018
ALBUTEROL SULFATE×2AMNEAL PHARMS COANDA 208804ABMay 21, 2018
ALBUTEROL SULFATELUOXIN AUROVITASANDA 206224ANOct 17, 2017
ALBUTEROL SULFATESUN PHARMANDA 207857ANJul 21, 2017
ALBUTEROL SULFATEAMNEAL PHARMSANDA 079241AAMay 12, 2010
ALBUTEROL SULFATE×2APOTEX INCANDA 078623—Apr 05, 2010
ALBUTEROL SULFATE×2NEPHRONANDA 076355ANMar 31, 2010
ALBUTEROL SULFATERITEDOSE CORPANDA 077839ANDec 16, 2008
ALBUTEROL SULFATE×2WATSON LABSANDA 077772—Sep 25, 2007
ALBUTEROL SULFATECHARTWELL RXANDA 077788AAJun 26, 2007
ALBUTEROL SULFATEAPOTEX INCANDA 075717—Feb 02, 2007
ALBUTEROL SULFATE×2RISINGANDA 078092—Jan 29, 2007
ALBUTEROL SULFATECHARTWELL MOLECULARANDA 078105AADec 27, 2006
ALBUTEROL SULFATELANDELA PHARMANDA 077569—Apr 04, 2006
ALBUTEROL SULFATEWATSON LABS INCANDA 076370—Nov 24, 2003
ALBUTEROL SULFATEAPOTEX INCANDA 076391—Apr 01, 2003
VOSPIRE ER×2STRIDES PHARMA INTLANDA 076130—Sep 26, 2002
ALBUTEROL SULFATENEPHRONANDA 075664ANJun 26, 2001
ALBUTEROL SULFATEROXANEANDA 075129—Feb 13, 2001
ALBUTEROL SULFATEBAUSCHANDA 075358—Mar 29, 2000
ALBUTEROL SULFATEWOCKHARDT EU OPERATNANDA 075394—Nov 22, 1999
ALBUTEROL SULFATETEVA PHARMSANDA 075343—Nov 09, 1999
ALBUTEROL SULFATEACTAVIS MID ATLANTICANDA 075262—Mar 30, 1999
ALBUTEROL SULFATEEPIC PHARMA LLCANDA 075063—Feb 09, 1999
ALBUTEROL SULFATEBAUSCHANDA 075050—Jun 18, 1998
ALBUTEROL SULFATEHIKMAANDA 074749—Jan 30, 1998
ALBUTEROL SULFATESENTISSANDA 074543ANJan 15, 1998
ALBUTEROL SULFATENEPHRONANDA 074880ANSep 17, 1997
ALBUTEROL SULFATEACTAVIS MID ATLANTICANDA 073533—Sep 26, 1995
ALBUTEROL SULFATECOSETTE PHARMS NCANDA 074454—Sep 25, 1995
ALBUTEROL SULFATEMOVAANDA 074302—Sep 30, 1994
ALBUTEROL SULFATETEVAANDA 072779—Jun 25, 1993
ALBUTEROL SULFATETEVAANDA 072780—Jun 25, 1993
ALBUTEROL SULFATECOPLEY PHARMANDA 073495—May 28, 1993
ALBUTEROL SULFATEWATSON LABSANDA 073165—Apr 29, 1993
ALBUTEROL SULFATEUCB INCANDA 073120—Sep 29, 1992
ALBUTEROL SULFATEUCB INCANDA 073121—Sep 29, 1992
ALBUTEROL SULFATETEVAANDA 073419AAMar 30, 1992
ALBUTEROL SULFATEPHARMOBEDIENTANDA 072652—Feb 21, 1992
ALBUTEROL SULFATECOPLEY PHARMANDA 073307—Nov 27, 1991
ALBUTEROL SULFATECOPLEY PHARMANDA 072966—Nov 22, 1991
ALBUTEROL SULFATECOPLEY PHARMANDA 072967—Nov 22, 1991
ALBUTEROL SULFATEWATSON LABSANDA 072764—Aug 28, 1991
ALBUTEROL SULFATEWATSON LABSANDA 072765—Aug 28, 1991
ALBUTEROL SULFATEWATSON LABSANDA 072629—Jan 31, 1991
ALBUTEROL SULFATEWATSON LABSANDA 072630—Jan 31, 1991
ALBUTEROL SULFATE×2NATCO PHARMA USAANDA 072894ABJan 17, 1991
ALBUTEROL SULFATETEVAANDA 072938—Mar 30, 1990
ALBUTEROL SULFATETEVAANDA 072939—Mar 30, 1990
ALBUTEROL SULFATEWARNER CHILCOTTANDA 072817—Jan 09, 1990
ALBUTEROL SULFATEWARNER CHILCOTTANDA 072818—Jan 09, 1990
ALBUTEROL SULFATE×2STRIDES PHARMA INTLANDA 072860—Dec 20, 1989
ALBUTEROL SULFATEAM THERAPANDA 072449—Dec 05, 1989
ALBUTEROL SULFATEAM THERAPANDA 072450—Dec 05, 1989
ALBUTEROL SULFATE×2CHARTWELL RXANDA 072151—Dec 05, 1989
ALBUTEROL SULFATEPLIVAANDA 072316—Dec 05, 1989
ALBUTEROL SULFATEPLIVAANDA 072317—Dec 05, 1989
ALBUTEROL SULFATE×2SUN PHARM INDUSTRIESANDA 072637ABDec 05, 1989
ALBUTEROL SULFATETEVAANDA 072619—Dec 05, 1989
ALBUTEROL SULFATETEVAANDA 072620—Dec 05, 1989

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Albuterol sulfate — frequently asked questions

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

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