Is there a generic for Mephentermine sulfate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Mephentermine sulfate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Mephentermine sulfate?

WYAMINE SULFATE (NDA 008248, BAXTER HLTHCARE CORP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Mephentermine sulfate are approved?

Mephentermine sulfate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Mephentermine sulfate

Mephentermine sulfate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:WYAMINE SULFATE · NDA 008248

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
WYAMINE SULFATE×2	BAXTER HLTHCARE CORP	NDA 008248	—	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.

Mephentermine sulfate — frequently asked questions

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

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