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Generated: April 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050733

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NDA 050733 describes ZITHROMAX, which is a drug marketed by Pfizer and is included in seven NDAs. It is available from thirteen 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. Sixty-four suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 050733
Tradename:ZITHROMAX
Applicant:Pfizer
Ingredient:azithromycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050733
Medical Subject Heading (MeSH) Categories for 050733
Suppliers and Packaging for NDA: 050733
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZITHROMAX azithromycin INJECTABLE;INJECTION 050733 NDA Pfizer Laboratories Div Pfizer Inc 0069-0400 0069-0400-10 10 VIAL in 1 CARTON (0069-0400-10) > 5 mL in 1 VIAL (0069-0400-01)
ZITHROMAX azithromycin INJECTABLE;INJECTION 050733 NDA Pfizer Laboratories Div Pfizer Inc 0069-3150 0069-3150-14 10 VIAL in 1 CARTON (0069-3150-14) > 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jan 30, 1997TE:APRLD:Yes

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