Details for New Drug Application (NDA): 061505
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NDA 061505 describes ERYTHROMYCIN STEARATE, which is a drug marketed by Ani Pharms, Lederle, Pharmobedient, Purepac Pharm, and Watson Labs, and is included in seven NDAs. Additional details are available on the ERYTHROMYCIN STEARATE profile page.
The generic ingredient in ERYTHROMYCIN STEARATE is erythromycin stearate. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin stearate profile page.
The generic ingredient in ERYTHROMYCIN STEARATE is erythromycin stearate. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin stearate profile page.
Summary for 061505
| Tradename: | ERYTHROMYCIN STEARATE |
| Applicant: | Pharmobedient |
| Ingredient: | erythromycin stearate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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