Details for New Drug Application (NDA): 211086
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NDA 211086 describes ERYTHROMYCIN LACTOBIONATE, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Exela Pharma, Nexus, and Teva Parenteral, and is included in five NDAs. It is available from two suppliers. Additional details are available on the ERYTHROMYCIN LACTOBIONATE profile page.
The generic ingredient in ERYTHROMYCIN LACTOBIONATE is erythromycin lactobionate. There are one hundred and three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the erythromycin lactobionate profile page.
The generic ingredient in ERYTHROMYCIN LACTOBIONATE is erythromycin lactobionate. There are one hundred and three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the erythromycin lactobionate profile page.
Summary for 211086
| Tradename: | ERYTHROMYCIN LACTOBIONATE |
| Applicant: | Exela Pharma |
| Ingredient: | erythromycin lactobionate |
| Patents: | 0 |
Pharmacology for NDA: 211086
| Physiological Effect | Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 211086
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN LACTOBIONATE | erythromycin lactobionate | INJECTABLE;INJECTION | 211086 | ANDA | Exela Pharma Sciences, LLC | 51754-7000 | 51754-7000-3 | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (51754-7000-3) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Sep 17, 2020 | TE: | RLD: | No | |||||
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