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Serving 500+ biopharmaceutical companies globally:

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Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205772

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NDA 205772 describes CALCIPOTRIENE, which is a drug marketed by Fougera Pharms, Tolmar, Glenmark Pharms Inc, G And W Labs Inc, Glenmark Pharms, Hi Tech Pharma, and Perrigo Israel, and is included in nine 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 NDA: 205772

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
CREAM;TOPICAL 205772 ANDA Glenmark Pharmaceuticals Inc.,USA 68462-501 68462-501-65 1 TUBE in 1 CARTON (68462-501-65) > 60 g in 1 TUBE
CREAM;TOPICAL 205772 ANDA Glenmark Pharmaceuticals Inc.,USA 68462-501 68462-501-66 1 TUBE in 1 CARTON (68462-501-66) > 120 g in 1 TUBE

Summary for product number 001

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

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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo
Fish and Richardson
Cantor Fitzgerald
Federal Trade Commission

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