Assyro AI

FDA Orange Book · active-ingredient family

Metaproterenol sulfate

Metaproterenol sulfate is approved as 5 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ALUPENT · NDA 018761

5

Brand (NDA)

31

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, metered, solution, syrup, tablet

ProductApplicantApplicationTEApproved
ALUPENT×2BOEHRINGER INGELHEIMNDA 018761Oct 10, 1986
ALUPENTBOEHRINGER INGELHEIMNDA 016402Approved Prior to Jan 1, 1982
ALUPENTBOEHRINGER INGELHEIMNDA 017659Approved Prior to Jan 1, 1982
ALUPENTBOEHRINGER INGELHEIMNDA 017571Approved Prior to Jan 1, 1982
ALUPENT×2BOEHRINGER INGELHEIMNDA 015874Approved Prior to Jan 1, 1982

Generic (ANDA) products (31)

ProductApplicantApplicationTEApproved
METAPROTERENOL SULFATE×2WOCKHARDTANDA 075586May 30, 2002
METAPROTERENOL SULFATEAPOTEX INCANDA 075402Feb 28, 2001
METAPROTERENOL SULFATEAPOTEX INCANDA 075403Feb 28, 2001
METAPROTERENOL SULFATEAPOTEX INCANDA 075235Jan 27, 2000
METAPROTERENOL SULFATEWOCKHARDTANDA 074702Mar 24, 1997
METAPROTERENOL SULFATECHARTWELLANDA 073632Jul 22, 1992
PROMETAMUROANDA 073340Mar 30, 1992
METAPROTERENOL SULFATECOSETTEANDA 072761Feb 27, 1992
METAPROTERENOL SULFATEG AND W LABS INCANDA 073034Aug 30, 1991
METAPROTERENOL SULFATEWATSON LABSANDA 073013Jan 31, 1991
METAPROTERENOL SULFATEWATSON LABSANDA 072795Jan 31, 1991
METAPROTERENOL SULFATEHERITAGE PHARMAANDA 072519Mar 30, 1990
METAPROTERENOL SULFATEHERITAGE PHARMAANDA 072520Mar 30, 1990
PROMETAMUROANDA 072023Sep 15, 1988
METAPROTERENOL SULFATEDEYANDA 071806Aug 05, 1988
METAPROTERENOL SULFATEDEYANDA 071805Aug 05, 1988
METAPROTERENOL SULFATEMYLAN SPECIALITY LPANDA 071786Aug 05, 1988
METAPROTERENOL SULFATEASTRAZENECAANDA 071275Jul 27, 1988
METAPROTERENOL SULFATEASTRAZENECAANDA 071018Jul 27, 1988
METAPROTERENOL SULFATENEPHRONANDA 071855Jul 14, 1988
METAPROTERENOL SULFATENEPHRONANDA 071726Jul 14, 1988
METAPROTERENOL SULFATESTRIDES PHARMA INTLANDA 072024Jun 28, 1988
METAPROTERENOL SULFATESTRIDES PHARMA INTLANDA 072025Jun 28, 1988
METAPROTERENOL SULFATEAM THERAPANDA 072054Jun 23, 1988
METAPROTERENOL SULFATEAM THERAPANDA 072055Jun 23, 1988
METAPROTERENOL SULFATEWOCKHARDTANDA 072190Jun 07, 1988
METAPROTERENOL SULFATEUSL PHARMAANDA 071013Jan 25, 1988
METAPROTERENOL SULFATEUSL PHARMAANDA 071014Jan 25, 1988
METAPROTERENOL SULFATEMORTON GROVEANDA 071656Oct 13, 1987
METAPROTERENOL SULFATEDEYANDA 070805Aug 17, 1987
METAPROTERENOL SULFATEMYLAN SPECIALITY LPANDA 070804Aug 17, 1987

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.

Metaproterenol sulfate — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.