Details for New Drug Application (NDA): 215290
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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 215290
Tradename: | ERYTHROMYCIN LACTOBIONATE |
Applicant: | Nexus |
Ingredient: | erythromycin lactobionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215290
Physiological Effect | Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 215290
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERYTHROMYCIN LACTOBIONATE | erythromycin lactobionate | INJECTABLE;INJECTION | 215290 | ANDA | Nexus Pharmaceuticals Inc. | 14789-116 | 14789-116-05 | 5 VIAL, GLASS in 1 BOX (14789-116-05) / 10 mL in 1 VIAL, GLASS (14789-116-07) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | Feb 14, 2022 | TE: | AP | RLD: | No |
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