Details for New Drug Application (NDA): 078305
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The generic ingredient in CALCIPOTRIENE 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 078305
Tradename: | CALCIPOTRIENE |
Applicant: | Fougera Pharms |
Ingredient: | calcipotriene |
Patents: | 0 |
Suppliers and Packaging for NDA: 078305
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CALCIPOTRIENE | calcipotriene | SOLUTION;TOPICAL | 078305 | ANDA | Fougera Pharmaceuticals Inc. | 0168-0400 | 0168-0400-60 | 60 mL in 1 BOTTLE, PLASTIC (0168-0400-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.005% | ||||
Approval Date: | May 6, 2008 | TE: | AT | RLD: | No |
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