Details for New Drug Application (NDA): 211204
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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 211204
Tradename: | ERYTHROMYCIN ETHYLSUCCINATE |
Applicant: | Amneal Pharms |
Ingredient: | erythromycin ethylsuccinate |
Patents: | 0 |
Pharmacology for NDA: 211204
Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 211204
Suppliers and Packaging for NDA: 211204
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN ETHYLSUCCINATE | erythromycin ethylsuccinate | GRANULE;ORAL | 211204 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1503 | 60219-1503-1 | 100 mL in 1 BOTTLE (60219-1503-1) |
ERYTHROMYCIN ETHYLSUCCINATE | erythromycin ethylsuccinate | GRANULE;ORAL | 211204 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1504 | 60219-1504-2 | 100 mL in 1 BOTTLE (60219-1504-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | EQ 200MG BASE/5ML | ||||
Approval Date: | Nov 1, 2019 | 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 1, 2019 | TE: | AB | RLD: | No |
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