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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050710

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NDA 050710 describes ZITHROMAX, which is a drug marketed by Pfizer and is included in seven NDAs. It is available from nine suppliers. Additional details are available on the ZITHROMAX profile page.

The generic ingredient in ZITHROMAX is azithromycin. There are thirty-two drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 050710
Tradename:ZITHROMAX
Applicant:Pfizer
Ingredient:azithromycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050710
Medical Subject Heading (MeSH) Categories for 050710
Suppliers and Packaging for NDA: 050710
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050710 NDA Pfizer Laboratories Div Pfizer Inc 0069-3110 0069-3110-19 1 BOTTLE in 1 CARTON (0069-3110-19) > 15 mL in 1 BOTTLE
ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050710 NDA Pfizer Laboratories Div Pfizer Inc 0069-3120 0069-3120-19 1 BOTTLE in 1 CARTON (0069-3120-19) > 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 100MG BASE/5ML
Approval Date:Oct 19, 1995TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 200MG BASE/5ML
Approval Date:Oct 19, 1995TE:ABRLD:Yes

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