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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205772

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NDA 205772 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 eight 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 205772
Tradename:CALCIPOTRIENE
Applicant:Glenmark Pharms
Ingredient:calcipotriene
Patents:0
Therapeutic Class:Dermatological Agents
Pharmacology for NDA: 205772
Ingredient-typeVitamin D
Suppliers and Packaging for NDA: 205772
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIPOTRIENE calcipotriene CREAM;TOPICAL 205772 ANDA Glenmark Pharmaceuticals Inc.,USA 68462-501 N 68462-501-65
CALCIPOTRIENE calcipotriene CREAM;TOPICAL 205772 ANDA Glenmark Pharmaceuticals Inc.,USA 68462-501 N 68462-501-66

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.005%
Approval Date:Jun 9, 2015TE:ABRLD:No

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