Details for New Drug Application (NDA): 050609
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NDA 050609 describes ERYTHROCIN, which is a drug marketed by Abbott, Hospira, and Azurity, and is included in five NDAs. It is available from one supplier. Additional details are available on the ERYTHROCIN profile page.
The generic ingredient in ERYTHROCIN 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 ERYTHROCIN 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 050609
| Tradename: | ERYTHROCIN |
| Applicant: | Hospira |
| Ingredient: | erythromycin lactobionate |
| Patents: | 0 |
Pharmacology for NDA: 050609
| Physiological Effect | Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 050609
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERYTHROCIN | erythromycin lactobionate | INJECTABLE;INJECTION | 050609 | NDA | Hospira, Inc. | 0409-6482 | 0409-6482-01 | 10 VIAL in 1 TRAY (0409-6482-01) / 10 mL in 1 VIAL (0409-6482-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Sep 24, 1986 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Sep 24, 1986 | TE: | RLD: | Yes | |||||
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