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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
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Dow
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US Department of Justice
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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018861

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NDA 018861 describes BETAMETHASONE VALERATE, which is a drug marketed by Perrigo Uk Finco, Riconpharma Llc, Taro Pharm, Fougera Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Taro, Sti Pharma Llc, Teva Pharms, and Actavis Mid Atlantic, and is included in eighteen NDAs. It is available from fourteen suppliers. Additional details are available on the BETAMETHASONE VALERATE profile page.

The generic ingredient in BETAMETHASONE VALERATE is betamethasone valerate. There are sixty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the betamethasone valerate profile page.
Summary for 018861
Tradename:BETAMETHASONE VALERATE
Applicant:Fougera Pharms Inc
Ingredient:betamethasone valerate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 018861
Medical Subject Heading (MeSH) Categories for 018861
Suppliers and Packaging for NDA: 018861
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETAMETHASONE VALERATE betamethasone valerate CREAM;TOPICAL 018861 NDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0040 N 0168-0040-15
BETAMETHASONE VALERATE betamethasone valerate CREAM;TOPICAL 018861 NDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0040 N 0168-0040-46

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 0.1% BASE
Approval Date:Aug 31, 1983TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Queensland Health
Mallinckrodt
Express Scripts
Baxter
Covington
QuintilesIMS
Moodys
Cerilliant

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