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Generated: November 13, 2018

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Details for New Drug Application (NDA): 050609

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NDA 050609 describes ERYTHROCIN, which is a drug marketed by Abbott, Hospira, and Arbor Pharms Llc, and is included in five NDAs. It is available from one supplier. Additional details are available on the ERYTHROCIN profile page.

The generic ingredient in ERYTHROCIN is erythromycin stearate. There are one hundred and three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the erythromycin stearate profile page.
Summary for 050609
Tradename:ERYTHROCIN
Applicant:Hospira
Ingredient:erythromycin lactobionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050609
Ingredient-typeMacrolides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 050609
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROCIN erythromycin lactobionate INJECTABLE;INJECTION 050609 NDA Hospira, Inc. 0409-6482 0409-6482-01 10 VIAL in 1 TRAY (0409-6482-01) > 10 mL in 1 VIAL (0409-6482-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Sep 24, 1986TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Sep 24, 1986TE:RLD:No

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