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Last Updated: January 20, 2021

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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, Fougera Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Anima, Teva Pharms, and Actavis Mid Atlantic, and is included in eighteen NDAs. It is available from eleven 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. Fifteen 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
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 0168-0040-15 15 g in 1 TUBE (0168-0040-15)
BETAMETHASONE VALERATE betamethasone valerate CREAM;TOPICAL 018861 NDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0040 0168-0040-46 45 g in 1 TUBE (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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