Details for New Drug Application (NDA): 062055
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NDA 062055 describes ERYTHROMYCIN ETHYLSUCCINATE, which is a drug marketed by Amneal Pharms, Ani Pharms, Cadila Pharms Ltd, Endo Operations, Alpharma Us Pharms, Dista, Naska, Parke Davis, Pharmafair, Aurobindo Pharma Usa, Azurity, and Barr, and is included in fourteen NDAs. It is available from five suppliers. Additional details are available on the ERYTHROMYCIN ETHYLSUCCINATE profile page.
The generic ingredient in ERYTHROMYCIN ETHYLSUCCINATE is erythromycin ethylsuccinate; sulfisoxazole acetyl. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin ethylsuccinate; sulfisoxazole acetyl profile page.
The generic ingredient in ERYTHROMYCIN ETHYLSUCCINATE is erythromycin ethylsuccinate; sulfisoxazole acetyl. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin ethylsuccinate; sulfisoxazole acetyl profile page.
Summary for 062055
| Tradename: | ERYTHROMYCIN ETHYLSUCCINATE |
| Applicant: | Ani Pharms |
| Ingredient: | erythromycin ethylsuccinate |
| Patents: | 0 |
Pharmacology for NDA: 062055
| Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 062055
Suppliers and Packaging for NDA: 062055
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN ETHYLSUCCINATE | erythromycin ethylsuccinate | GRANULE;ORAL | 062055 | ANDA | ANI Pharmaceuticals, Inc. | 62559-440 | 62559-440-02 | 200 mL in 1 BOTTLE (62559-440-02) |
| ERYTHROMYCIN ETHYLSUCCINATE | erythromycin ethylsuccinate | GRANULE;ORAL | 062055 | ANDA | ANI Pharmaceuticals, Inc. | 62559-630 | 62559-630-01 | 100 mL in 1 BOTTLE (62559-630-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | EQ 200MG BASE/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | EQ 400MG BASE/5ML | ||||
| Approval Date: | Nov 2, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | EQ 200MG BASE/5ML | ||||
| Approval Date: | Nov 2, 2018 | TE: | AB | RLD: | No | ||||
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