Details for New Drug Application (NDA): 050611
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NDA 050611 describes PCE, which is a drug marketed by Azurity and is included in one NDA. Additional details are available on the PCE profile page.
The generic ingredient in PCE is erythromycin. There are one hundred and three drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the erythromycin profile page.
The generic ingredient in PCE is erythromycin. There are one hundred and three drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the erythromycin profile page.
Summary for 050611
| Tradename: | PCE |
| Applicant: | Azurity |
| Ingredient: | erythromycin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050611
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, COATED PARTICLES;ORAL | Strength | 333MG | ||||
| Approval Date: | Sep 9, 1986 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, COATED PARTICLES;ORAL | Strength | 500MG | ||||
| Approval Date: | Aug 22, 1990 | TE: | RLD: | Yes | |||||
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