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Details for New Drug Application (NDA): 018738
The generic ingredient in EXELDERM is sulconazole nitrate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sulconazole nitrate profile page.
Summary for 018738
Tradename: | EXELDERM |
Applicant: | Sun Pharm Inds Inc |
Ingredient: | sulconazole nitrate |
Patents: | 0 |
Therapeutic Class: | Antifungals |
Pharmacology for NDA: 018738
Ingredient-type | Azoles |
Suppliers and Packaging for NDA: 018738
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EXELDERM | sulconazole nitrate | SOLUTION;TOPICAL | 018738 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-100 | N | 10631-100-30 |
EXELDERM | sulconazole nitrate | SOLUTION;TOPICAL | 018738 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-100 | N | 10631-100-04 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 1% | ||||
Approval Date: | Aug 30, 1985 | TE: | RLD: | Yes |
Expired US Patents for NDA 018738
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sun Pharm Inds Inc | EXELDERM | sulconazole nitrate | SOLUTION;TOPICAL | 018738-001 | Aug 30, 1985 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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