Details for New Drug Application (NDA): 216569
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The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.
Summary for 216569
Tradename: | CLOTRIMAZOLE |
Applicant: | Sciegen Pharms Inc |
Ingredient: | clotrimazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216569
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOTRIMAZOLE | clotrimazole | SOLUTION;TOPICAL | 216569 | ANDA | ScieGen Pharmaceuticals, Inc | 50228-502 | 50228-502-08 | 1 BOTTLE in 1 CARTON (50228-502-08) / 10 mL in 1 BOTTLE |
CLOTRIMAZOLE | clotrimazole | SOLUTION;TOPICAL | 216569 | ANDA | ScieGen Pharmaceuticals, Inc | 50228-502 | 50228-502-30 | 1 BOTTLE in 1 CARTON (50228-502-30) / 30 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 1% | ||||
Approval Date: | Oct 16, 2023 | TE: | AT | RLD: | No |
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