Details for New Drug Application (NDA): 210765
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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 210765
| Tradename: | CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE |
| Applicant: | Cosette |
| Ingredient: | betamethasone dipropionate; calcipotriene |
| Patents: | 0 |
Pharmacology for NDA: 210765
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 210765
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 210765 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0848 | 0713-0848-60 | 1 BOTTLE in 1 CARTON (0713-0848-60) / 60 g in 1 BOTTLE |
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 210765 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0848 | 0713-0848-92 | 2 BOTTLE in 1 CARTON (0713-0848-92) / 60 g in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;TOPICAL | Strength | 0.064%;0.005% | ||||
| Approval Date: | May 11, 2020 | TE: | AB | RLD: | No | ||||
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