FDA Orange Book · active-ingredient family
Albuterol
Albuterol: 2 brands, 4 generics; first approved Dec 28, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
4
Listed patents
0
Presentations
6
Brand (NDA) products
Originator applications
- SCHERINGNDA 017559—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.09MG/INH AEROSOL, METERED INHALATION Discontinued — - GLAXOSMITHKLINENDA 018473—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.09MG/INH AEROSOL, METERED INHALATION Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- ALBUTEROLGENPHARMANDA 0730451997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.09MG/INH AEROSOL, METERED INHALATION Discontinued — - ALBUTEROLARMSTRONG PHARMSANDA 0722731996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.09MG/INH AEROSOL, METERED INHALATION Discontinued — - ALBUTEROLPLIVAANDA 0740721996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.09MG/INH AEROSOL, METERED INHALATION Discontinued — - ALBUTEROLIVAX SUB TEVA PHARMSANDA 0732721995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.09MG/INH AEROSOL, METERED INHALATION Discontinued —
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
31 yr 1 mo ago
Most recent approval
29 yr 5 mo ago
Approvals span 1995–1997 across 6 FDA applications.
Brand (NDA) 233%
Generic (ANDA) 467%
Albuterol: 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.
