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Details for New Drug Application (NDA): 050693

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NDA 050693 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 twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the azithromycin profile page.

Summary for NDA: 050693

Tradename:
ZITHROMAX
Applicant:
Pfizer
Ingredient:
azithromycin
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050693

Ingredient-typeMacrolides

Suppliers and Packaging for NDA: 050693

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZITHROMAX
azithromycin
FOR SUSPENSION;ORAL 050693 NDA Pfizer Laboratories Div Pfizer Inc 0069-3051 0069-3051-07 10 PACKET in 1 BOX (0069-3051-07) > 1 POWDER, FOR SUSPENSION in 1 PACKET
ZITHROMAX
azithromycin
FOR SUSPENSION;ORAL 050693 NDA Pfizer Laboratories Div Pfizer Inc 0069-3051 0069-3051-75 3 PACKET in 1 BOX (0069-3051-75) > 1 POWDER, FOR SUSPENSION in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 1GM BASE/PACKET
Approval Date:Sep 28, 1994TE:RLD:Yes
Patent:6,268,489Patent Expiration:Jul 31, 2018Product Flag?Substance Flag?YDelist Request?


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