Is there a generic for Tinzaparin sodium?

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

What is the reference-listed drug for Tinzaparin sodium?

INNOHEP (NDA 020484, LEO PHARMA AS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tinzaparin sodium are approved?

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

FDA Orange Book · active-ingredient family

Tinzaparin sodium

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

Reference-listed drug:INNOHEP · NDA 020484

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
INNOHEP	LEO PHARMA AS	NDA 020484	—	Jul 14, 2000

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.

Tinzaparin sodium — frequently asked questions

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

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