Last Updated: July 14, 2026

Details for New Drug Application (NDA): 216761


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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 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.
Summary for 216761
Tradename:ERYTHROMYCIN LACTOBIONATE
Applicant:Gland
Ingredient:erythromycin lactobionate
Patents:0
Pharmacology for NDA: 216761
Physiological EffectDecreased 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 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)
ERYTHROMYCIN LACTOBIONATE erythromycin lactobionate INJECTABLE;INJECTION 216761 ANDA Armas Pharmaceuticals Inc. 72485-701 72485-701-10 10 VIAL, SINGLE-DOSE in 1 CARTON (72485-701-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72485-701-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Nov 19, 2024TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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