Details for New Drug Application (NDA): 050746
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The generic ingredient in BACTROBAN is mupirocin. There are sixteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the mupirocin profile page.
Summary for 050746
| Tradename: | BACTROBAN |
| Applicant: | Glaxosmithkline |
| Ingredient: | mupirocin calcium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 11, 1997 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 050746
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | BACTROBAN | mupirocin calcium | CREAM;TOPICAL | 050746-001 | Dec 11, 1997 | 6,025,389 | ⤷ Start Trial |
| Glaxosmithkline | BACTROBAN | mupirocin calcium | CREAM;TOPICAL | 050746-001 | Dec 11, 1997 | 5,569,672 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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