Is there a generic for Azathioprine sodium?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Azathioprine sodium, referencing the brand IMURAN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Azathioprine sodium?

IMURAN (NDA 017391, CASPER PHARMA LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Azathioprine sodium are approved?

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

FDA Orange Book · active-ingredient family

Azathioprine sodium

Azathioprine sodium is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:IMURAN · NDA 017391

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
IMURANRLD	CASPER PHARMA LLC	NDA 017391	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
AZATHIOPRINE SODIUM	HIKMA	ANDA 074419	—	Mar 31, 1995

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.

Azathioprine sodium — frequently asked questions

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

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