FDA Orange Book · active-ingredient family
Metaproterenol sulfate
Metaproterenol sulfate: 5 brands, 31 generics; first approved Jun 30, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 31 ANDA applications approved.
Brands (NDA)
5
Generics (ANDA)
31
Listed patents
0
Presentations
39
Brand (NDA) products
Originator applications
- BOEHRINGER INGELHEIMNDA 01876119862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.6% SOLUTION INHALATION Discontinued - 0.4% SOLUTION INHALATION Discontinued - - BOEHRINGER INGELHEIMNDA 016402-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.65MG/INH AEROSOL, METERED INHALATION Discontinued - - BOEHRINGER INGELHEIMNDA 017659-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5% SOLUTION INHALATION Discontinued - - BOEHRINGER INGELHEIMNDA 017571-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Discontinued - - BOEHRINGER INGELHEIMNDA 015874-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued -
Generic (ANDA) products (31)
Abbreviated applications
- METAPROTERENOL SULFATEWOCKHARDTANDA 07558620022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4% SOLUTION INHALATION Discontinued - 0.6% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATEAPOTEX INCANDA 0754022001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATEAPOTEX INCANDA 0754032001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.6% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATEAPOTEX INCANDA 0752352000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Discontinued - - METAPROTERENOL SULFATEWOCKHARDTANDA 0747021997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Discontinued - - METAPROTERENOL SULFATERSCHARTWELLANDA 0736321992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Rx - - MUROANDA 0733401992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATECOSETTE PHARMS NCANDA 0727611992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Discontinued - - METAPROTERENOL SULFATEG AND W LABS INCANDA 0730341991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Discontinued - - METAPROTERENOL SULFATEWATSON LABSANDA 0730131991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METAPROTERENOL SULFATEWATSON LABSANDA 0727951991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - METAPROTERENOL SULFATEHERITAGE PHARMAANDA 0725191990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METAPROTERENOL SULFATEHERITAGE PHARMAANDA 0725201990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - MUROANDA 0720231988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Discontinued - - METAPROTERENOL SULFATEDEYANDA 0718061988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.33% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATEDEYANDA 0718051988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATEMYLAN SPECIALITY LPANDA 0717861988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATEASTRAZENECAANDA 0712751988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATEASTRAZENECAANDA 0710181988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.6% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATENEPHRONANDA 0718551988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATENEPHRONANDA 0717261988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.6% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATESTRIDES PHARMA INTLANDA 0720241988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METAPROTERENOL SULFATESTRIDES PHARMA INTLANDA 0720251988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - METAPROTERENOL SULFATEAM THERAPANDA 0720541988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METAPROTERENOL SULFATEAM THERAPANDA 0720551988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - METAPROTERENOL SULFATEWOCKHARDTANDA 0721901988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATEUSL PHARMAANDA 0710131988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - METAPROTERENOL SULFATEUSL PHARMAANDA 0710141988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - METAPROTERENOL SULFATEMORTON GROVEANDA 0716561987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SYRUP ORAL Discontinued - - METAPROTERENOL SULFATEDEYANDA 0708051987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5% SOLUTION INHALATION Discontinued - - METAPROTERENOL SULFATEMYLAN SPECIALITY LPANDA 0708041987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.6% SOLUTION 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
43 yr 11 mo ago
Most recent approval
24 yr 9 mo ago
Approvals span 1983–2002 across 36 FDA applications.
Brand (NDA) 514%
Generic (ANDA) 3186%
Metaproterenol sulfate: 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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