Methscopolamine bromide
Methscopolamine bromide: 1 brand, 5 generics; first approved Mar 25, 2003; generic available.
Generic available: 5 ANDA applications approved.
Brand (NDA) products
- FOUGERANDA 008848—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued —
Generic (ANDA) products (5)
- METHSCOPOLAMINE BROMIDENE RX PHARMAANDA 21678620242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AA 5MG TABLET ORAL Rx AA - METHSCOPOLAMINE BROMIDEUNICHEMANDA 20060220122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AA 5MG TABLET ORAL Rx AA - METHSCOPOLAMINE BROMIDEBRECKENRIDGE PHARMANDA 04064220112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AA 5MG TABLET ORAL Rx AA - METHSCOPOLAMINE BROMIDECHARTWELL RXANDA 04062420062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - METHSCOPOLAMINE BROMIDEPVT FORMANDA 080970—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL 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 2003–2024 across 6 FDA applications.
Methscopolamine bromide: 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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