Details for New Drug Application (NDA): 216761
NDA 216761 describes ERYTHROMYCIN LACTOBIONATE, which is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Exela Pharma, Gland, Nexus, and Teva Parenteral, and is included in six NDAs. It is available from three suppliers. Additional details are available on the ERYTHROMYCIN LACTOBIONATE profile page.
The generic ingredient in ERYTHROMYCIN LACTOBIONATE is erythromycin lactobionate. There is one drug master file entry for this compound. Four 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 is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the erythromycin lactobionate profile page.
Summary for 216761
| Tradename: | ERYTHROMYCIN LACTOBIONATE |
| Applicant: | Gland |
| Ingredient: | erythromycin lactobionate |
| Patents: | 0 |
Pharmacology for NDA: 216761
| Physiological Effect | Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 216761
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN LACTOBIONATE | erythromycin lactobionate | INJECTABLE;INJECTION | 216761 | ANDA | Piramal Critical Care Inc. | 66794-251 | 66794-251-41 | 10 VIAL in 1 CARTON (66794-251-41) / 500 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-251-02) |
| ERYTHROMYCIN LACTOBIONATE | erythromycin lactobionate | INJECTABLE;INJECTION | 216761 | ANDA | Gland Pharma Limited | 68083-513 | 68083-513-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Nov 19, 2024 | TE: | AP | RLD: | No | ||||
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