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. 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. Sixty 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:	1
Formulation / Manufacturing:	see details

Pharmacology for NDA: 050733

Ingredient-type	Macrolides

Medical Subject Heading (MeSH) Categories for 050733

Anti-Bacterial Agents

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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jan 30, 1997	TE:	AP	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Jul 31, 2018	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 050733

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZITHROMAX	azithromycin	INJECTABLE;INJECTION	050733-001	Jan 30, 1997	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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