Alupent
Metaproterenol Sulfate
Sourced from the FDA Orange Book
Key dates
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
METAPROTERENOL SULFATE
Strength
20MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 015874
Product number
001
Marketing status
Discontinued
Reference listed drug (RLD)
No
Reference standard (RS)
No
Other strengths in NDA 015874
Active-ingredient family
This is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1986AlupentBrand (NDA)
NDA 018761 · Boehringer Ingelheim
- —AlupentBrand (NDA)
NDA 016402 · Boehringer Ingelheim
- —AlupentBrand (NDA)
NDA 017659 · Boehringer Ingelheim
- —AlupentBrand (NDA)
NDA 017571 · Boehringer Ingelheim
- 2002Metaproterenol SulfateGeneric (ANDA)
ANDA 075586 · Wockhardt
- 2001Metaproterenol SulfateGeneric (ANDA)
ANDA 075402 · Apotex Inc
- 2001Metaproterenol SulfateGeneric (ANDA)
ANDA 075403 · Apotex Inc
- 2000Metaproterenol SulfateGeneric (ANDA)
ANDA 075235 · Apotex Inc
- 1997Metaproterenol SulfateGeneric (ANDA)
ANDA 074702 · Wockhardt
- 1992Metaproterenol SulfateGeneric (ANDA)
ANDA 073632 · Chartwell
- 1992PrometaGeneric (ANDA)
ANDA 073340 · Muro
- 1992Metaproterenol SulfateGeneric (ANDA)
ANDA 072761 · Cosette
Listed patents
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.
Alupent — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Metaproterenol Sulfate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

