Is there a generic for Anisotropine methylbromide?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Anisotropine methylbromide, referencing the brand VALPIN 50. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Anisotropine methylbromide?

VALPIN 50 (NDA 013428, ENDO PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Anisotropine methylbromide are approved?

Anisotropine methylbromide is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Anisotropine methylbromide

Anisotropine methylbromide is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VALPIN 50 · NDA 013428

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
VALPIN 50	ENDO PHARMS	NDA 013428	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
ANISOTROPINE METHYLBROMIDE	WATSON LABS	ANDA 086046	—	Approved Prior to Jan 1, 1982

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.

Anisotropine methylbromide — frequently asked questions

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

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