Is there a generic for Ergotamine tartrate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Ergotamine tartrate, referencing the brand MEDIHALER ERGOTAMINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ergotamine tartrate?

MEDIHALER ERGOTAMINE (NDA 012102, 3M) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ergotamine tartrate are approved?

Ergotamine tartrate is approved in the following dosage forms: aerosol, metered, tablet.

FDA Orange Book · active-ingredient family

Ergotamine tartrate

Ergotamine tartrate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MEDIHALER ERGOTAMINE · NDA 012102

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, metered, tablet

Product	Applicant	Application	TE	Approved
MEDIHALER ERGOTAMINE	3M	NDA 012102	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
ERGOSTAT	WATSON LABS INC	ANDA 088337	—	Jun 08, 1984
ERGOMAR	PANGEA	ANDA 087693	—	Feb 24, 1983
WIGRETTES	ORGANON USA INC	ANDA 086750	—	Jul 29, 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.

Ergotamine tartrate — frequently asked questions

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

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