Details for New Drug Application (NDA): 076543

NDA 076543 describes BETAMETHASONE DIPROPIONATE, which is a drug marketed by Anda Repository, 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, Tasman Pharma, 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 076543

Tradename:	BETAMETHASONE DIPROPIONATE
Applicant:	Taro
Ingredient:	betamethasone dipropionate
Patents:	0

Pharmacology for NDA: 076543

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 076543

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	076543	ANDA	A-S Medication Solutions	50090-5232	50090-5232-0	1 TUBE in 1 CARTON (50090-5232-0) / 50 g in 1 TUBE
BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	076543	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-1310	51672-1310-1	1 TUBE in 1 CARTON (51672-1310-1) / 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM, AUGMENTED;TOPICAL			Strength	EQ 0.05% BASE
Approval Date:	Dec 9, 2003	TE:	AB	RLD:	No

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