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Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200935

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NDA 200935 describes CALCIPOTRIENE, which is a drug marketed by Glenmark Pharms, Tolmar, Glenmark Pharms Inc, Fougera Pharms, G And W Labs Inc, Hi Tech Pharma, Novel Labs Inc, and Perrigo Israel, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the CALCIPOTRIENE profile page.

The generic ingredient in CALCIPOTRIENE is betamethasone dipropionate; calcipotriene hydrate. There are sixty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene hydrate profile page.
Summary for 200935
Tradename:CALCIPOTRIENE
Applicant:Tolmar
Ingredient:calcipotriene
Patents:0
Therapeutic Class:Dermatological Agents
Pharmacology for NDA: 200935
Ingredient-typeVitamin D
Suppliers and Packaging for NDA: 200935
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIPOTRIENE calcipotriene CREAM;TOPICAL 200935 ANDA Sandoz Inc. 0781-7117 N 0781-7117-35
CALCIPOTRIENE calcipotriene CREAM;TOPICAL 200935 ANDA Sandoz Inc. 0781-7117 N 0781-7117-83

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.005%
Approval Date:May 30, 2012TE:ABRLD:No

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