Details for New Drug Application (NDA): 050417
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NDA 050417 describes LUMI-SPORYN, which is a drug marketed by Casper Pharma Llc and is included in one NDA. Additional details are available on the LUMI-SPORYN profile page.
The generic ingredient in LUMI-SPORYN is bacitracin zinc; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bacitracin zinc; neomycin sulfate; polymyxin b sulfate profile page.
The generic ingredient in LUMI-SPORYN is bacitracin zinc; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bacitracin zinc; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 050417
| Tradename: | LUMI-SPORYN |
| Applicant: | Casper Pharma Llc |
| Ingredient: | bacitracin zinc; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** | ||||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: | AT | RLD: | Yes | ||||
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