Is there a generic for Dinoprost tromethamine?

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

What is the reference-listed drug for Dinoprost tromethamine?

PROSTIN F2 ALPHA (NDA 017434, PHARMACIA AND UPJOHN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dinoprost tromethamine are approved?

Dinoprost tromethamine is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Dinoprost tromethamine

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

Reference-listed drug:PROSTIN F2 ALPHA · NDA 017434

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
PROSTIN F2 ALPHA	PHARMACIA AND UPJOHN	NDA 017434	—	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.

Dinoprost tromethamine — frequently asked questions

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

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