Details for New Drug Application (NDA): 062305
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NDA 062305 describes PEDIAMYCIN, which is a drug marketed by Ross Labs and Arbor Pharms Llc and is included in three NDAs. Additional details are available on the PEDIAMYCIN profile page.
The generic ingredient in PEDIAMYCIN is erythromycin ethylsuccinate. There are one hundred and three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the erythromycin ethylsuccinate profile page.
The generic ingredient in PEDIAMYCIN is erythromycin ethylsuccinate. There are one hundred and three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the erythromycin ethylsuccinate profile page.
Summary for 062305
| Tradename: | PEDIAMYCIN |
| Applicant: | Ross Labs |
| Ingredient: | erythromycin ethylsuccinate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 062305
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | GRANULE;ORAL | Strength | EQ 200MG BASE/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION/DROPS;ORAL | Strength | EQ 100MG BASE/2.5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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