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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 018866

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NDA 018866 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 018866

Tradename:	BETAMETHASONE VALERATE
Applicant:	Fougera Pharms Inc
Ingredient:	betamethasone valerate
Patents:	0

Pharmacology for NDA: 018866

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 018866

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 018866

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BETAMETHASONE VALERATE	betamethasone valerate	LOTION;TOPICAL	018866	NDA	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0168-0041	0168-0041-60	60 mL in 1 BOTTLE (0168-0041-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LOTION;TOPICAL			Strength	EQ 0.1% BASE
Approval Date:	Aug 31, 1983	TE:	AB	RLD:	Yes

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