Is there a generic for Ardeparin sodium?

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

What is the reference-listed drug for Ardeparin sodium?

NORMIFLO (NDA 020227, 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 Ardeparin sodium are approved?

Ardeparin sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ardeparin sodium

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

Reference-listed drug:NORMIFLO · NDA 020227

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
NORMIFLORLD×2	PHARMACIA AND UPJOHN	NDA 020227	—	May 23, 1997

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.

Ardeparin sodium — frequently asked questions

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

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