Details for New Drug Application (NDA): 215185
✉ Email this page to a colleague
The generic ingredient in KETOCONAZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 215185
Tradename: | KETOCONAZOLE |
Applicant: | Tasman Pharma |
Ingredient: | ketoconazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 215185
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOCONAZOLE | ketoconazole | CREAM;TOPICAL | 215185 | ANDA | Tasman Pharma Inc. | 72641-005 | 72641-005-15 | 1 TUBE in 1 CARTON (72641-005-15) / 15 g in 1 TUBE |
KETOCONAZOLE | ketoconazole | CREAM;TOPICAL | 215185 | ANDA | Tasman Pharma Inc. | 72641-005 | 72641-005-30 | 1 TUBE in 1 CARTON (72641-005-30) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2% | ||||
Approval Date: | Nov 17, 2021 | TE: | AB | RLD: | No |
Complete Access Available with Subscription