Is there a generic for Beclomethasone dipropionate monohydrate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Beclomethasone dipropionate monohydrate. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Beclomethasone dipropionate monohydrate?

BECONASE AQ (NDA 019389, GLAXOSMITHKLINE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Beclomethasone dipropionate monohydrate are approved?

Beclomethasone dipropionate monohydrate is approved in the following dosage form: spray, metered.

FDA Orange Book · active-ingredient family

Beclomethasone dipropionate monohydrate

Beclomethasone dipropionate monohydrate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:BECONASE AQ · NDA 019389

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · spray, metered

Product	Applicant	Application	TE	Approved
BECONASE AQRLD	GLAXOSMITHKLINE	NDA 019389	—	Jul 27, 1987
VANCENASE AQ	SCHERING	NDA 020469	—	Jun 26, 1996
VANCENASE AQ	SCHERING	NDA 019589	—	Dec 23, 1987

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.

Beclomethasone dipropionate monohydrate — frequently asked questions

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

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