Is there a generic for Dexamethasone acetate?

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

What is the reference-listed drug for Dexamethasone acetate?

DECADRON-LA (NDA 016675, MERCK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dexamethasone acetate are approved?

Dexamethasone acetate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Dexamethasone acetate

Dexamethasone acetate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DECADRON-LA · NDA 016675

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
DECADRON-LARLD	MERCK	NDA 016675	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
DEXAMETHASONE ACETATE	WATSON LABS TEVA	ANDA 087711	—	May 24, 1982
DEXAMETHASONE ACETATE	WATSON LABS	ANDA 084315	—	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.

Dexamethasone acetate — frequently asked questions

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

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