Details for New Drug Application (NDA): 061621
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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 061621
Tradename: | ERYTHROMYCIN |
Applicant: | Azurity |
Ingredient: | erythromycin |
Patents: | 0 |
Pharmacology for NDA: 061621
Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 061621
Suppliers and Packaging for NDA: 061621
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN | erythromycin | TABLET;ORAL | 061621 | ANDA | Arbor Pharmaceuticals, Inc. | 24338-102 | 24338-102-03 | 30 TABLET, FILM COATED in 1 BOTTLE (24338-102-03) |
ERYTHROMYCIN | erythromycin | TABLET;ORAL | 061621 | ANDA | Arbor Pharmaceuticals, Inc. | 24338-102 | 24338-102-13 | 100 TABLET, FILM COATED in 1 BOTTLE (24338-102-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No |
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