Details for New Drug Application (NDA): 018738
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The generic ingredient in EXELDERM is sulconazole nitrate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the sulconazole nitrate profile page.
Summary for 018738
| Tradename: | EXELDERM |
| Applicant: | Journey |
| Ingredient: | sulconazole nitrate |
| Patents: | 0 |
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 | Journey Medical Corporation | 69489-721 | 69489-721-05 | 5 mL in 1 BOTTLE (69489-721-05) |
| EXELDERM | sulconazole nitrate | SOLUTION;TOPICAL | 018738 | NDA | Journey Medical Corporation | 69489-721 | 69489-721-30 | 1 BOTTLE in 1 CARTON (69489-721-30) / 30 mL in 1 BOTTLE |
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 |
|---|---|---|---|---|---|---|---|
| Journey | EXELDERM | sulconazole nitrate | SOLUTION;TOPICAL | 018738-001 | Aug 30, 1985 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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