Details for New Drug Application (NDA): 061904
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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 061904
Tradename: | ERYTHROMYCIN ETHYLSUCCINATE |
Applicant: | Arbor Pharms Llc |
Ingredient: | erythromycin ethylsuccinate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 061904
Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 061904
Suppliers and Packaging for NDA: 061904
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN ETHYLSUCCINATE | erythromycin ethylsuccinate | TABLET;ORAL | 061904 | ANDA | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-110 | 24338-110-03 | 30 TABLET in 1 BOTTLE (24338-110-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | BX | RLD: | No |
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