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
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALUPENT×2 | BOEHRINGER INGELHEIM | NDA 018761 | — | Oct 10, 1986 | |
| ALUPENT | BOEHRINGER INGELHEIM | NDA 016402 | — | Approved Prior to Jan 1, 1982 | |
| ALUPENT | BOEHRINGER INGELHEIM | NDA 017659 | — | Approved Prior to Jan 1, 1982 | |
| ALUPENT | BOEHRINGER INGELHEIM | NDA 017571 | — | Approved Prior to Jan 1, 1982 | |
| ALUPENT×2 | BOEHRINGER INGELHEIM | NDA 015874 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (31)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METAPROTERENOL SULFATE×2 | WOCKHARDT | ANDA 075586 | — | May 30, 2002 | |
| METAPROTERENOL SULFATE | APOTEX INC | ANDA 075402 | — | Feb 28, 2001 | |
| METAPROTERENOL SULFATE | APOTEX INC | ANDA 075403 | — | Feb 28, 2001 | |
| METAPROTERENOL SULFATE | APOTEX INC | ANDA 075235 | — | Jan 27, 2000 | |
| METAPROTERENOL SULFATE | WOCKHARDT | ANDA 074702 | — | Mar 24, 1997 | |
| METAPROTERENOL SULFATE | CHARTWELL | ANDA 073632 | — | Jul 22, 1992 | |
| PROMETA | MURO | ANDA 073340 | — | Mar 30, 1992 | |
| METAPROTERENOL SULFATE | COSETTE | ANDA 072761 | — | Feb 27, 1992 | |
| METAPROTERENOL SULFATE | G AND W LABS INC | ANDA 073034 | — | Aug 30, 1991 | |
| METAPROTERENOL SULFATE | WATSON LABS | ANDA 073013 | — | Jan 31, 1991 | |
| METAPROTERENOL SULFATE | WATSON LABS | ANDA 072795 | — | Jan 31, 1991 | |
| METAPROTERENOL SULFATE | HERITAGE PHARMA | ANDA 072519 | — | Mar 30, 1990 | |
| METAPROTERENOL SULFATE | HERITAGE PHARMA | ANDA 072520 | — | Mar 30, 1990 | |
| PROMETA | MURO | ANDA 072023 | — | Sep 15, 1988 | |
| METAPROTERENOL SULFATE | DEY | ANDA 071806 | — | Aug 05, 1988 | |
| METAPROTERENOL SULFATE | DEY | ANDA 071805 | — | Aug 05, 1988 | |
| METAPROTERENOL SULFATE | MYLAN SPECIALITY LP | ANDA 071786 | — | Aug 05, 1988 | |
| METAPROTERENOL SULFATE | ASTRAZENECA | ANDA 071275 | — | Jul 27, 1988 | |
| METAPROTERENOL SULFATE | ASTRAZENECA | ANDA 071018 | — | Jul 27, 1988 | |
| METAPROTERENOL SULFATE | NEPHRON | ANDA 071855 | — | Jul 14, 1988 | |
| METAPROTERENOL SULFATE | NEPHRON | ANDA 071726 | — | Jul 14, 1988 | |
| METAPROTERENOL SULFATE | STRIDES PHARMA INTL | ANDA 072024 | — | Jun 28, 1988 | |
| METAPROTERENOL SULFATE | STRIDES PHARMA INTL | ANDA 072025 | — | Jun 28, 1988 | |
| METAPROTERENOL SULFATE | AM THERAP | ANDA 072054 | — | Jun 23, 1988 | |
| METAPROTERENOL SULFATE | AM THERAP | ANDA 072055 | — | Jun 23, 1988 | |
| METAPROTERENOL SULFATE | WOCKHARDT | ANDA 072190 | — | Jun 07, 1988 | |
| METAPROTERENOL SULFATE | USL PHARMA | ANDA 071013 | — | Jan 25, 1988 | |
| METAPROTERENOL SULFATE | USL PHARMA | ANDA 071014 | — | Jan 25, 1988 | |
| METAPROTERENOL SULFATE | MORTON GROVE | ANDA 071656 | — | Oct 13, 1987 | |
| METAPROTERENOL SULFATE | DEY | ANDA 070805 | — | Aug 17, 1987 | |
| METAPROTERENOL SULFATE | MYLAN SPECIALITY LP | ANDA 070804 | — | Aug 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.

