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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 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: 050609

erythromycin lactobionate
Therapeutic Class:Antibacterials

Pharmacology for NDA: 050609

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
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

Summary for product number 001

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

Summary for product number 002

Approval Date:Sep 24, 1986TE:RLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.