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Details for New Drug Application (NDA): 050797

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NDA 050797 describes ZMAX, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the ZMAX profile page.

The generic ingredient in ZMAX is azithromycin. There are thirty drug master file entries for this compound. Fifty-five 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: 050797

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050797


Suppliers and Packaging for NDA: 050797

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797 NDA Pfizer Laboratories Div Pfizer Inc 0069-4170 0069-4170-34 1 BOTTLE in 1 CARTON (0069-4170-34) > 60 mL in 1 BOTTLE
FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797 NDA Rebel Distributors Corp 21695-444 21695-444-60 60 mL in 1 BOTTLE (21695-444-60)

Summary for product number 001

Approval Date:Jun 10, 2005TE:RLD:Yes
Patent:6,068,859Patent Expiration:May 30, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:6,268,489Patent Expiration:Jul 31, 2018Product Flag?Substance Flag?YDelist Request?
Patent:7,887,844Patent Expiration:Feb 14, 2024Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.