Details for New Drug Application (NDA): 062447
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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. Two suppliers are listed for this compound. Additional details are available on the erythromycin stearate profile page.
Summary for 062447
Tradename: | ERYTHROMYCIN |
Applicant: | Padagis Us |
Ingredient: | erythromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 062447
Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 062447
Suppliers and Packaging for NDA: 062447
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN | erythromycin | OINTMENT;OPHTHALMIC | 062447 | ANDA | Padagis US LLC | 0574-4024 | 0574-4024-35 | 1 TUBE in 1 CARTON (0574-4024-35) / 3.5 g in 1 TUBE |
ERYTHROMYCIN | erythromycin | OINTMENT;OPHTHALMIC | 062447 | ANDA | Padagis US LLC | 0574-4024 | 0574-4024-39 | 24 TUBE in 1 CARTON (0574-4024-39) / 3.5 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 0.5% | ||||
Approval Date: | Sep 26, 1983 | TE: | AT | RLD: | No |
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