Details for New Drug Application (NDA): 205772
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NDA 205772 describes CALCIPOTRIENE, which is a drug marketed by Chartwell Rx, Glenmark Speclt, Glenmark Pharms Inc, Cosette, Fougera Pharms, Hikma, Glenmark Pharms Ltd, Padagis Israel, and Taro, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the CALCIPOTRIENE profile page.
The generic ingredient in CALCIPOTRIENE 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 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 205772
| Tradename: | CALCIPOTRIENE |
| Applicant: | Glenmark Speclt |
| Ingredient: | calcipotriene |
| Patents: | 0 |
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 | Northstar Rx LLC | 16714-763 | 16714-763-01 | 1 TUBE in 1 CARTON (16714-763-01) / 60 g in 1 TUBE |
| CALCIPOTRIENE | calcipotriene | CREAM;TOPICAL | 205772 | ANDA | Northstar Rx LLC | 16714-763 | 16714-763-02 | 1 TUBE in 1 CARTON (16714-763-02) / 120 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.005% | ||||
| Approval Date: | Jun 9, 2015 | TE: | AB | RLD: | No | ||||
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