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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
Baxter
Medtronic
Mallinckrodt
US Army
Johnson and Johnson
Harvard Business School
UBS

Generated: April 20, 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 Si Pharms 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:Si Pharms
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 E 59630-821-12
CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686 NDA Sciele Pharma, Inc. 59630-821 E 59630-821-90

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SUSPENSION;ORALStrengthEQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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SUSPENSION;ORALStrengthEQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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
Si Pharms CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686-001 Dec 20, 1995 ➤ Sign Up ➤ Sign Up
Si Pharms CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686-002 Dec 20, 1995 ➤ Sign Up ➤ Sign Up
Si Pharms CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686-002 Dec 20, 1995 ➤ Sign Up ➤ Sign Up
Si Pharms CEDAX ceftibuten dihydrate FOR SUSPENSION;ORAL 050686-001 Dec 20, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Accenture
Chubb
Boehringer Ingelheim
Julphar
Moodys
McKinsey
QuintilesIMS
Baxter

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