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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 076603

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NDA 076603 describes BETAMETHASONE DIPROPIONATE, which is a drug marketed by Chartwell Molecular, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Sun Pharma Canada, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Encube, Hikma, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Aurobindo Pharma Ltd, Lupin Ltd, Tp Anda Holdings, and Zydus Lifesciences, and is included in forty-seven NDAs. It is available from twenty-three suppliers. Additional details are available on the BETAMETHASONE DIPROPIONATE profile page.

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

Summary for 076603

Tradename:	BETAMETHASONE DIPROPIONATE
Applicant:	Chartwell Molecular
Ingredient:	betamethasone dipropionate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM, AUGMENTED;TOPICAL			Strength	EQ 0.05% BASE
Approval Date:	Jan 23, 2004	TE:		RLD:	No

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