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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 204965

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NDA 204965 describes DESOXIMETASONE, which is a drug marketed by Actavis Mid Atlantic, Cosette, Fougera Pharms, Lupin, Padagis Israel, Rising, Sciegen Pharms, Zydus Lifesciences, Epic Pharma Llc, Padagis Us, Altana, Glenmark Pharms Ltd, Novel Labs Inc, Pai Holdings Pharm, and The J Molner, and is included in thirty NDAs. It is available from eleven suppliers. Additional details are available on the DESOXIMETASONE profile page.

The generic ingredient in DESOXIMETASONE is desoximetasone. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.

Summary for 204965

Tradename:	DESOXIMETASONE
Applicant:	Actavis Mid Atlantic
Ingredient:	desoximetasone
Patents:	0

Pharmacology for NDA: 204965

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 204965

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 204965

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESOXIMETASONE	desoximetasone	OINTMENT;TOPICAL	204965	ANDA	Actavis Pharma, Inc.	0472-0479	0472-0479-15	1 TUBE in 1 CARTON (0472-0479-15) / 15 g in 1 TUBE
DESOXIMETASONE	desoximetasone	OINTMENT;TOPICAL	204965	ANDA	Actavis Pharma, Inc.	0472-0479	0472-0479-60	1 TUBE in 1 CARTON (0472-0479-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.25%
Approval Date:	Nov 7, 2016	TE:	AB	RLD:	No

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