Details for New Drug Application (NDA): 075638
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NDA 075638 describes KETOZOLE, which is a drug marketed by Sun Pharma Canada and is included in one NDA. It is available from seven suppliers. Additional details are available on the KETOZOLE profile page.
The generic ingredient in KETOZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
The generic ingredient in KETOZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 075638
| Tradename: | KETOZOLE |
| Applicant: | Sun Pharma Canada |
| Ingredient: | ketoconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075638
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETOZOLE | ketoconazole | CREAM;TOPICAL | 075638 | ANDA | NORTHSTAR RX LLC | 16714-955 | 16714-955-01 | 1 TUBE in 1 CARTON (16714-955-01) / 15 g in 1 TUBE |
| KETOZOLE | ketoconazole | CREAM;TOPICAL | 075638 | ANDA | NORTHSTAR RX LLC | 16714-955 | 16714-955-02 | 1 TUBE in 1 CARTON (16714-955-02) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2% | ||||
| Approval Date: | Dec 18, 2002 | TE: | AB | RLD: | No | ||||
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