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Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050784


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NDA 050784 describes ZITHROMAX, which is a drug marketed by Pfizer and is included in seven NDAs. It is available from five 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-five suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 050784
Tradename:ZITHROMAX
Applicant:Pfizer
Ingredient:azithromycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050784
Medical Subject Heading (MeSH) Categories for 050784
Suppliers and Packaging for NDA: 050784
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZITHROMAX azithromycin TABLET;ORAL 050784 NDA Pfizer Laboratories Div Pfizer Inc 0069-3070 0069-3070-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-3070-30)
ZITHROMAX azithromycin TABLET;ORAL 050784 NDA Pfizer Laboratories Div Pfizer Inc 0069-3070 0069-3070-75 3 BLISTER PACK in 1 CARTON (0069-3070-75) > 3 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:May 24, 2002TE:ABRLD:Yes

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