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Express Scripts
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Johnson and Johnson
Queensland Health
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Generated: May 24, 2018

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 fourteen suppliers. There is one patent protecting this drug and one Paragraph IV challenge. 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-eight 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:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050710
Ingredient-typeMacrolides
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 N 0069-3110-19
ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050710 NDA Pfizer Laboratories Div Pfizer Inc 0069-3120 N 0069-3120-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 100MG BASE/5ML
Approval Date:Oct 19, 1995TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 31, 2018Product Flag?Substance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 200MG BASE/5ML
Approval Date:Oct 19, 1995TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 31, 2018Product Flag?Substance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
UBS
AstraZeneca
QuintilesIMS
Harvard Business School
Healthtrust
Baxter
Chinese Patent Office
Citi

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