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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 210639

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NDA 210639 describes BETAMETHASONE VALERATE, which is a drug marketed by Alembic, Novast Labs, Padagis Israel, Taro, Xiromed, Fougera Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Sun Pharma Canada, Senores Pharms, Teva Pharms, and Actavis Mid Atlantic, and is included in twenty NDAs. It is available from eight suppliers. Additional details are available on the BETAMETHASONE VALERATE profile page.

The generic ingredient in BETAMETHASONE VALERATE is betamethasone valerate. There are sixty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the betamethasone valerate profile page.

Summary for 210639

Tradename:	BETAMETHASONE VALERATE
Applicant:	Xiromed
Ingredient:	betamethasone valerate
Patents:	0

Pharmacology for NDA: 210639

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 210639

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 210639

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BETAMETHASONE VALERATE	betamethasone valerate	AEROSOL, FOAM;TOPICAL	210639	ANDA	Xiromed, LLC.	70700-141	70700-141-19	1 CANISTER in 1 CARTON (70700-141-19) / 50 g in 1 CANISTER
BETAMETHASONE VALERATE	betamethasone valerate	AEROSOL, FOAM;TOPICAL	210639	ANDA	Xiromed, LLC.	70700-141	70700-141-20	1 CANISTER in 1 CARTON (70700-141-20) / 100 g in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	0.12%
Approval Date:	Apr 18, 2023	TE:	AB	RLD:	No

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