Details for New Drug Application (NDA): 063038
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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. One supplier is listed for this compound. Additional details are available on the erythromycin stearate profile page.
Summary for 063038
Tradename: | ERYTHROMYCIN |
Applicant: | Padagis Us |
Ingredient: | erythromycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 063038
Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 063038
Suppliers and Packaging for NDA: 063038
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN | erythromycin | SOLUTION;TOPICAL | 063038 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-038 | 45802-038-46 | 1 BOTTLE in 1 CARTON (45802-038-46) / 60 mL in 1 BOTTLE |
ERYTHROMYCIN | erythromycin | SOLUTION;TOPICAL | 063038 | ANDA | Bryant Ranch Prepack | 72162-2075 | 72162-2075-6 | 1 BOTTLE in 1 CARTON (72162-2075-6) / 60 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 2% | ||||
Approval Date: | Jan 11, 1991 | TE: | AT | RLD: | No |
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