Details for New Drug Application (NDA): 214549
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The generic ingredient in ERYTHROMYCIN 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 214549
Tradename: | ERYTHROMYCIN |
Applicant: | Teva Pharms Usa Inc |
Ingredient: | erythromycin |
Patents: | 0 |
Pharmacology for NDA: 214549
Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 214549
Suppliers and Packaging for NDA: 214549
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN | erythromycin | TABLET;ORAL | 214549 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5571 | 0093-5571-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-5571-01) |
ERYTHROMYCIN | erythromycin | TABLET;ORAL | 214549 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5571 | 0093-5571-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-5571-56) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Feb 11, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Feb 11, 2021 | TE: | AB | RLD: | No |
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