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Generated: September 22, 2017

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Details for New Drug Application (NDA): 072538

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NDA 072538 describes BETAMETHASONE DIPROPIONATE, which is a drug marketed by Tolmar, Actavis Mid Atlantic, Taro, Fougera Pharms, Perrigo New York, Glenmark Generics, Pharmaderm, Fougera Pharms Inc, 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: 072538

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 072538

Suppliers and Packaging for NDA: 072538

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETAMETHASONE DIPROPIONATE
betamethasone dipropionate
LOTION;TOPICAL 072538 ANDA Perrigo New York Inc 45802-021 45802-021-46 1 BOTTLE, PLASTIC in 1 CARTON (45802-021-46) > 56.2 g in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrengthEQ 0.05% BASE
Approval Date:Jan 31, 1990TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Colorcon
Federal Trade Commission
McKesson
Mallinckrodt
Argus Health
Chinese Patent Office
Julphar
US Army
UBS

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