Is there a generic for Betamethasone benzoate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Betamethasone benzoate. It is available as 4 brand (NDA) applications.

What is the reference-listed drug for Betamethasone benzoate?

UTICORT (NDA 016998, PARKE DAVIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Betamethasone benzoate are approved?

Betamethasone benzoate is approved in the following dosage forms: cream, gel, lotion, ointment.

FDA Orange Book · active-ingredient family

Betamethasone benzoate

Betamethasone benzoate is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:UTICORT · NDA 016998

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream, gel, lotion, ointment

Product	Applicant	Application	TE	Approved
UTICORT	PARKE DAVIS	NDA 016998	—	Approved Prior to Jan 1, 1982
UTICORT	PARKE DAVIS	NDA 017244	—	Approved Prior to Jan 1, 1982
UTICORT	PARKE DAVIS	NDA 017528	—	Approved Prior to Jan 1, 1982
UTICORT	PARKE DAVIS	NDA 018089	—	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.

Betamethasone benzoate — frequently asked questions

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

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