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Details for New Drug Application (NDA): 062638

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NDA 062638 describes ERYTHROCIN, which is a drug marketed by Hospira, Abbott, 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 ninety-seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the erythromycin stearate profile page.

Summary for NDA: 062638

Tradename:
ERYTHROCIN
Applicant:
Hospira
Ingredient:
erythromycin lactobionate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 062638

Ingredient-typeMacrolides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 062638

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROCIN
erythromycin lactobionate
INJECTABLE;INJECTION 062638 ANDA Hospira, Inc. 0409-6476 0409-6476-44 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-6476-44) > 100 mL in 1 VIAL, PATENT DELIVERY SYSTEM

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Oct 31, 1986TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Oct 31, 1986TE:RLD:Yes


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