Details for New Drug Application (NDA): 062447
✉ Email this page to a colleague
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 062447
| Tradename: | ERYTHROMYCIN |
| Applicant: | Padagis Us |
| Ingredient: | erythromycin |
| Patents: | 0 |
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: | DISCN | Dosage: | OINTMENT;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Sep 26, 1983 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
