Details for New Drug Application (NDA): 017381
The generic ingredient in SILVADENE is silver sulfadiazine. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the silver sulfadiazine profile page.
Summary for 017381
| Tradename: | SILVADENE |
| Applicant: | King Pharms Llc |
| Ingredient: | silver sulfadiazine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 017381
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SILVADENE | silver sulfadiazine | CREAM;TOPICAL | 017381 | NDA | A-S Medication Solutions | 50090-0230 | 50090-0230-0 | 1 TUBE in 1 CARTON (50090-0230-0) / 20 g in 1 TUBE |
| SILVADENE | silver sulfadiazine | CREAM;TOPICAL | 017381 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-0131 | 59762-0131-0 | 1 TUBE in 1 CARTON (59762-0131-0) / 20 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 017381
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| King Pharms Llc | SILVADENE | silver sulfadiazine | CREAM;TOPICAL | 017381-001 | Approved Prior to Jan 1, 1982 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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