Details for New Drug Application (NDA): 216212
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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 216212
Tradename: | ERYTHROMYCIN ETHYLSUCCINATE |
Applicant: | Cadila Pharms Ltd |
Ingredient: | erythromycin ethylsuccinate |
Patents: | 0 |
Pharmacology for NDA: 216212
Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 216212
Suppliers and Packaging for NDA: 216212
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN ETHYLSUCCINATE | erythromycin ethylsuccinate | GRANULE;ORAL | 216212 | ANDA | Cadila Pharmaceuticals Limited | 71209-102 | 71209-102-21 | 100 mL in 1 BOTTLE (71209-102-21) |
ERYTHROMYCIN ETHYLSUCCINATE | erythromycin ethylsuccinate | GRANULE;ORAL | 216212 | ANDA | Cadila Pharmaceuticals Limited | 71209-103 | 71209-103-21 | 100 mL in 1 BOTTLE (71209-103-21) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | EQ 200MG BASE/5ML | ||||
Approval Date: | Nov 21, 2022 | 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 21, 2022 | TE: | AB | RLD: | No |
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