Details for New Drug Application (NDA): 201615
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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. Eight suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 201615
Tradename: | CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE |
Applicant: | Chartwell Rx |
Ingredient: | betamethasone dipropionate; calcipotriene |
Patents: | 0 |
Pharmacology for NDA: 201615
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 201615
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 201615 | ANDA | Sandoz Inc. | 0781-7165 | 0781-7165-35 | 1 TUBE in 1 CARTON (0781-7165-35) / 60 g in 1 TUBE |
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 201615 | ANDA | Sandoz Inc. | 0781-7165 | 0781-7165-95 | 1 TUBE in 1 CARTON (0781-7165-95) / 100 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | OINTMENT;TOPICAL | Strength | 0.064%;0.005% | ||||
Approval Date: | Jan 14, 2013 | TE: | RLD: | No |
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