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Details for New Drug Application (NDA): 078930

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NDA 078930 describes BETAMETHASONE DIPROPIONATE, which is a drug marketed by Tolmar, Actavis Mid Atlantic, Taro, Fougera Pharms, Perrigo New York, Glenmark Generics, Pharmaderm, Fougera, G And W Labs Inc, Teva, and Alpharma Us Pharms, and is included in thirty-five NDAs. It is available from eighteen 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-one suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

Summary for NDA: 078930

Tradename:
BETAMETHASONE DIPROPIONATE
Applicant:
Glenmark Generics
Ingredient:
betamethasone dipropionate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 078930

Suppliers and Packaging for NDA: 078930

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETAMETHASONE DIPROPIONATE
betamethasone dipropionate
CREAM, AUGMENTED;TOPICAL 078930 ANDA A-S Medication Solutions 50090-2091 50090-2091-0 50 g in 1 TUBE (50090-2091-0)
BETAMETHASONE DIPROPIONATE
betamethasone dipropionate
CREAM, AUGMENTED;TOPICAL 078930 ANDA H.J. Harkins Company, Inc. 52959-124 52959-124-50 50 g in 1 TUBE (52959-124-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM, AUGMENTED;TOPICALStrengthEQ 0.05% BASE
Approval Date:Sep 23, 2008TE:ABRLD:No


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