Is there a generic for Cosyntropin?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Cosyntropin, referencing the brand CORTROSYN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cosyntropin?

CORTROSYN (NDA 016750, AMPHASTAR PHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cosyntropin are approved?

Cosyntropin is approved in the following dosage forms: injectable, solution.

FDA Orange Book · active-ingredient family

Cosyntropin

Cosyntropin is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CORTROSYN · NDA 016750

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, solution

Product	Applicant	Application	TE	Approved
CORTROSYNRLD	AMPHASTAR PHARMS INC	NDA 016750	AP	Approved Prior to Jan 1, 1982
COSYNTROPIN	SANDOZ	NDA 022028	—	Feb 21, 2008

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
COSYNTROPIN	SANDOZ	ANDA 202147	AP	Jun 29, 2012
COSYNTROPIN	PHARMOBEDIENT	ANDA 090574	—	Dec 17, 2009

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.

Cosyntropin — frequently asked questions

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

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