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Serving leading biopharmaceutical companies globally:

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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050686

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NDA 050686 describes CEDAX, which is a drug marketed by Pernix Therap and is included in two NDAs. It is available from one supplier. Additional details are available on the CEDAX profile page.

The generic ingredient in CEDAX is ceftibuten dihydrate. One supplier is listed for this compound. Additional details are available on the ceftibuten dihydrate profile page.
Summary for 050686
Tradename:CEDAX
Applicant:Pernix Therap
Ingredient:ceftibuten dihydrate
Patents:0
Therapeutic Class:Antibacterials
Pharmacology for NDA: 050686
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 050686
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686 NDA Sciele Pharma, Inc. 59630-821 59630-821-60 1 BOTTLE in 1 CARTON (59630-821-60) > 60 mL in 1 BOTTLE
CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686 NDA Sciele Pharma, Inc. 59630-821 59630-821-90 1 BOTTLE in 1 CARTON (59630-821-90) > 90 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 20, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 20, 1995TE:RLD:Yes

Expired US Patents for NDA 050686

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Therap CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686-002 Dec 20, 1995 ➤ Subscribe ➤ Subscribe
Pernix Therap CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686-001 Dec 20, 1995 ➤ Subscribe ➤ Subscribe
Pernix Therap CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686-001 Dec 20, 1995 ➤ Subscribe ➤ Subscribe
Pernix Therap CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686-002 Dec 20, 1995 ➤ Subscribe ➤ Subscribe
Pernix Therap CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686-002 Dec 20, 1995 ➤ Subscribe ➤ Subscribe
Pernix Therap CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686-001 Dec 20, 1995 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Healthtrust
Chubb
Novartis
Fuji
AstraZeneca
Daiichi Sankyo
Queensland Health
US Army
Dow

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