Details for New Drug Application (NDA): 200174
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NDA 200174 describes CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, which is a drug marketed by Glenmark Pharms Ltd, Chartwell Rx, Padagis Israel, Cosette, and Taro, and is included in five NDAs. It is available from four suppliers. Additional details are available on the CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE profile page.
The generic ingredient in CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
The generic ingredient in CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 200174
| Tradename: | CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE |
| Applicant: | Padagis Israel |
| Ingredient: | betamethasone dipropionate; calcipotriene |
| Patents: | 0 |
Pharmacology for NDA: 200174
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 200174
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 200174 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-816 | 45802-816-01 | 1 TUBE in 1 CARTON (45802-816-01) / 100 g in 1 TUBE |
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 200174 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-816 | 45802-816-96 | 1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.064%;0.005% | ||||
| Approval Date: | Dec 12, 2014 | TE: | AB | RLD: | No | ||||
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