FDA Orange Book · active-ingredient family
Albuterol sulfate
Albuterol sulfate: 15 brands, 77 generics; first approved May 07, 1982; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 77 ANDA applications approved.
Latest exclusivity ends
Brands (NDA)
15
Generics (ANDA)
77
Listed patents
0
Presentations
117
Brand (NDA) products
Originator applications
- TEVA BRANDED PHARMNDA 20563620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH POWDER, METERED INHALATION Rx — EQ 0.09MG BASE/INH POWDER, METERED INHALATION Discontinued — - TEVA BRANDED PHARMNDA 0214572004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH AEROSOL, METERED INHALATION Rx AB2 - ACCUNEBRLDPHARMOBEDIENTNDA 02094920012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.042% BASE SOLUTION INHALATION Discontinued — EQ 0.021% BASE SOLUTION INHALATION Discontinued — - GLAXOSMITHKLINENDA 0209832001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH AEROSOL, METERED INHALATION Rx AB3 - KINDEVANDA 0205031996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH AEROSOL, METERED INHALATION Rx AB1 - VOLMAXRLDMURONDA 01960419922 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - VENTOLINRLDGLAXOSMITHKLINENDA 0197731992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - PROVENTILRLDSCHERINGNDA 01924319872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION INHALATION Discontinued — EQ 0.083% BASE SOLUTION INHALATION Discontinued — - PROVENTILRLDSCHERINGNDA 0180621983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Discontinued — - PROVENTILRLDSCHERINGNDA 01785319822 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — EQ 4MG BASE TABLET ORAL Discontinued — - GLAXOSMITHKLINENDA 0194891988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.2MG BASE CAPSULE INHALATION Discontinued — - SCHERINGNDA 0193831987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - GLAXOSMITHKLINENDA 0196211987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Discontinued — - GLAXOSMITHKLINENDA 0192691987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION INHALATION Discontinued — - GLAXOSMITHKLINENDA 01911219862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — EQ 4MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (77)
Abbreviated applications
- ALBUTEROL SULFATECIPLAANDA 2194092026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH AEROSOL, METERED INHALATION Rx AB3 - ALBUTEROL SULFATEAMNEAL IRELAND LTDANDA 2116002025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH AEROSOL, METERED INHALATION Rx AB2 - ALBUTEROL SULFATERITEDOSE CORPANDA 2183862025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATEARMSTRONG PHARMSANDA 2124472024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH AEROSOL, METERED INHALATION Rx AB2 - ALBUTEROL SULFATELEXENPHARMANDA 21557120242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.021% BASE SOLUTION INHALATION Rx AN EQ 0.042% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATERSRITEDOSE CORPANDA 21453120212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.021% BASE SOLUTION INHALATION Rx AN EQ 0.042% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATESANDOZANDA 2070852021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH AEROSOL, METERED INHALATION Rx AB1 - ALBUTEROL SULFATEZYDUS PHARMSANDA 20888420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Rx AB EQ 4MG BASE TABLET ORAL Rx AB - ALBUTEROL SULFATEHIBROW HLTHCAREANDA 21352420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATELUPINANDA 2099542020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH AEROSOL, METERED INHALATION Rx AB2 - ALBUTEROL SULFATEAUROBINDO PHARMA LTDANDA 21365720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATELUOXIN AUROVITASANDA 21188820202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.021% BASE SOLUTION INHALATION Rx AN EQ 0.042% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATECIPLAANDA 2099592020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH AEROSOL, METERED INHALATION Rx AB1 - ALBUTEROL SULFATEPADAGIS USANDA 2037602020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/INH AEROSOL, METERED INHALATION Rx AB2 - ALBUTEROL SULFATEQUAGENANDA 2121972019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Rx AA - ALBUTEROL SULFATEAIZANTANDA 21094820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Rx BX EQ 4MG BASE TABLET ORAL Rx BX - ALBUTEROL SULFATEACERTIS PHARMSANDA 21139720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Rx AB EQ 4MG BASE TABLET ORAL Rx AB - ALBUTEROL SULFATERISINGANDA 20704620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Rx AB EQ 4MG BASE TABLET ORAL Rx AB - ALBUTEROL SULFATEAMNEAL PHARMS COANDA 20880420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Rx AB EQ 4MG BASE TABLET ORAL Rx AB - ALBUTEROL SULFATELUOXIN AUROVITASANDA 2062242017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATESUN PHARMANDA 2078572017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATEAMNEAL PHARMSANDA 0792412010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Rx AA - ALBUTEROL SULFATEAPOTEX INCANDA 07862320102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.021% BASE SOLUTION INHALATION Discontinued — EQ 0.042% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATENEPHRONANDA 07635520102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.042% BASE SOLUTION INHALATION Rx AN EQ 0.021% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATERITEDOSE CORPANDA 0778392008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATEWATSON LABSANDA 07777220072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.021% BASE SOLUTION INHALATION Discontinued — EQ 0.042% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATECHARTWELL RXANDA 0777882007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Rx AA - ALBUTEROL SULFATEAPOTEX INCANDA 0757172007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATERISINGANDA 07809220072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 8MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - ALBUTEROL SULFATECHARTWELL MOLECULARANDA 0781052006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Rx AA - ALBUTEROL SULFATELANDELA PHARMANDA 0775692006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATEWATSON LABS INCANDA 0763702003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATEAPOTEX INCANDA 0763912003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION INHALATION Discontinued — - STRIDES PHARMA INTLANDA 07613020022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 8MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - ALBUTEROL SULFATERSNEPHRONANDA 0756642001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATEROXANEANDA 0751292001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATEBAUSCHANDA 0753582000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATEWOCKHARDT EU OPERATNANDA 0753941999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATETEVA PHARMSANDA 0753431999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATEACTAVIS MID ATLANTICANDA 0752621999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Discontinued — - ALBUTEROL SULFATEEPIC PHARMA LLCANDA 0750631999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATEBAUSCHANDA 0750501998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATEHIKMAANDA 0747491998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Discontinued — - ALBUTEROL SULFATESENTISSANDA 0745431998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATERSNEPHRONANDA 0748801997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Rx AN - ALBUTEROL SULFATEACTAVIS MID ATLANTICANDA 0735331995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATECOSETTE PHARMS NCANDA 0744541995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Discontinued — - ALBUTEROL SULFATEMOVAANDA 0743021994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Discontinued — - ALBUTEROL SULFATETEVAANDA 0727791993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATETEVAANDA 0727801993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATECOPLEY PHARMANDA 0734951993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATEWATSON LABSANDA 0731651993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Discontinued — - ALBUTEROL SULFATEUCB INCANDA 0731201992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEUCB INCANDA 0731211992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATERSTEVAANDA 0734191992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/5ML SYRUP ORAL Rx AA - ALBUTEROL SULFATEPHARMOBEDIENTANDA 0726521992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.083% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATECOPLEY PHARMANDA 0733071991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5% BASE SOLUTION INHALATION Discontinued — - ALBUTEROL SULFATECOPLEY PHARMANDA 0729661991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATECOPLEY PHARMANDA 0729671991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEWATSON LABSANDA 0727641991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEWATSON LABSANDA 0727651991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEWATSON LABSANDA 0726291991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEWATSON LABSANDA 0726301991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATENATCO PHARMA USAANDA 07289419912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATETEVAANDA 0729381990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATETEVAANDA 0729391990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEWARNER CHILCOTTANDA 0728171990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEWARNER CHILCOTTANDA 0728181990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATESTRIDES PHARMA INTLANDA 07286019892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEAM THERAPANDA 0724491989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEAM THERAPANDA 0724501989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATECHARTWELL RXANDA 07215119892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEPLIVAANDA 0723161989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATEPLIVAANDA 0723171989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATESUN PHARM INDUSTRIESANDA 07263719892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - ALBUTEROL SULFATETEVAANDA 0726191989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET ORAL Discontinued — - ALBUTEROL SULFATETEVAANDA 0726201989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- CGTFDA marketing exclusivity
in 4 mo
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
44 yr 11 mo ago
Most recent approval
4 mo ago
Approvals span 1982–2026 across 92 FDA applications.
Brand (NDA) 1516%
Generic (ANDA) 7784%
Albuterol sulfate: 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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- 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.
