Pirbuterol acetate
Pirbuterol acetate: 2 brands, 0 generics; first approved Dec 30, 1986.
No listed patents or exclusivity: brand product(s) only.
Brand (NDA) products
- BAUSCHNDA 0200141992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.2MG BASE/INH AEROSOL, METERED INHALATION Discontinued - - BAUSCHNDA 0190091986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.2MG BASE/INH AEROSOL, METERED INHALATION Discontinued -
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.
Approval history
Approvals span 1986–1992 across 2 FDA applications.
Pirbuterol acetate: 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.
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