Details for New Drug Application (NDA): 075373

NDA 075373 describes BETAMETHASONE DIPROPIONATE, which is a drug marketed by Chartwell Molecular, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Taro, 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, Trupharma, and Zydus Lifesciences, and is included in forty-seven NDAs. It is available from twenty-two 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-five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

Summary for 075373

Tradename:	BETAMETHASONE DIPROPIONATE
Applicant:	Fougera Pharms
Ingredient:	betamethasone dipropionate
Patents:	0

Pharmacology for NDA: 075373

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 075373

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	OINTMENT, AUGMENTED;TOPICAL	075373	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0268	0168-0268-15	15 g in 1 TUBE (0168-0268-15)
BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	OINTMENT, AUGMENTED;TOPICAL	075373	ANDA	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0168-0268	0168-0268-50	50 g in 1 TUBE (0168-0268-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT, AUGMENTED;TOPICAL			Strength	EQ 0.05% BASE
Approval Date:	Jun 22, 1999	TE:	AB	RLD:	No

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