Details for New Drug Application (NDA): 050514
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NDA 050514 describes NATACYN, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from two suppliers. Additional details are available on the NATACYN profile page.
The generic ingredient in NATACYN is natamycin. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the natamycin profile page.
The generic ingredient in NATACYN is natamycin. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the natamycin profile page.
Summary for 050514
| Tradename: | NATACYN |
| Applicant: | Harrow Eye |
| Ingredient: | natamycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050514
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NATACYN | natamycin | SUSPENSION;OPHTHALMIC | 050514 | NDA | Eyevance Pharmaceuticals, LLC | 71776-005 | 71776-005-15 | 1 BOTTLE, GLASS in 1 CARTON (71776-005-15) / 15 mL in 1 BOTTLE, GLASS |
| NATACYN | natamycin | SUSPENSION;OPHTHALMIC | 050514 | NDA | Harrow Eye, LLC | 82667-012 | 82667-012-05 | 1 BOTTLE, GLASS in 1 CARTON (82667-012-05) / 15 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;OPHTHALMIC | Strength | 5% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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