Details for New Drug Application (NDA): 212367
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NDA 212367 describes CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE, which is a drug marketed by Padagis Israel and is included in one NDA. It is available from one supplier. Additional details are available on the CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE profile page.
The generic ingredient in CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
The generic ingredient in CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 212367
| Tradename: | CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE |
| Applicant: | Padagis Israel |
| Ingredient: | betamethasone dipropionate; calcipotriene |
| Patents: | 0 |
Pharmacology for NDA: 212367
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 212367
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 212367 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-889 | 45802-889-18 | 2 BOTTLE in 1 CARTON (45802-889-18) / 60 g in 1 BOTTLE |
| CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 212367 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-889 | 45802-889-96 | 1 BOTTLE in 1 CARTON (45802-889-96) / 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: | Sep 11, 2020 | TE: | AB | RLD: | No | ||||
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