Details for New Drug Application (NDA): 061229
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NDA 061229 describes POLYSPORIN, which is a drug marketed by Glaxosmithkline and Monarch Pharms and is included in two NDAs. Additional details are available on the POLYSPORIN profile page.
The generic ingredient in POLYSPORIN is bacitracin zinc; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bacitracin zinc; polymyxin b sulfate profile page.
The generic ingredient in POLYSPORIN is bacitracin zinc; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bacitracin zinc; polymyxin b sulfate profile page.
Summary for 061229
| Tradename: | POLYSPORIN |
| Applicant: | Monarch Pharms |
| Ingredient: | bacitracin zinc; polymyxin b sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | OINTMENT;OPHTHALMIC | Strength | 500 UNITS/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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