Details for New Drug Application (NDA): 050368
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NDA 050368 describes ILOTYCIN, which is a drug marketed by Dista and is included in three NDAs. Additional details are available on the ILOTYCIN profile page.
The generic ingredient in ILOTYCIN is erythromycin gluceptate. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin gluceptate profile page.
The generic ingredient in ILOTYCIN is erythromycin gluceptate. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin gluceptate profile page.
Summary for 050368
| Tradename: | ILOTYCIN |
| Applicant: | Dista |
| Ingredient: | erythromycin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050368
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | OINTMENT;OPHTHALMIC | Strength | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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