FDA Orange Book

Generic for Pamine Forte

Pamine Forte contains methscopolamine bromide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Pamine Forte is methscopolamine bromide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

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Pamine Forte products in the Orange Book

Pamine Forte products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral5MGDiscontinuedNone3AA

NDA 008848, held by FOUGERA PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic methscopolamine bromide

Approved generic versions of Pamine Forte
CompanyANDATE codeApprovedStrengths
BRECKENRIDGE PHARMACEUTICAL INC040642AA (A-rated, therapeutically equivalent)December 6, 20115MG
UNICHEM LABORATORIES LTD200602AA (A-rated, therapeutically equivalent)September 24, 20125MG
NE RX PHARMA LLC216786AA (A-rated, therapeutically equivalent)February 1, 20245MG

Questions

Is there a generic for Pamine Forte?

Yes. The generic name for Pamine Forte is methscopolamine bromide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

What is the generic name for Pamine Forte?

The active ingredient in Pamine Forte is methscopolamine bromide, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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