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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Covington
Colorcon
US Department of Justice
Farmers Insurance
Fuji
Citi
McKesson
Mallinckrodt
Julphar

Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021222

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NDA 021222 describes SPECTRACEF, which is a drug marketed by Vansen Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the SPECTRACEF profile page.

The generic ingredient in SPECTRACEF is cefditoren pivoxil. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cefditoren pivoxil profile page.
Summary for 021222
Tradename:SPECTRACEF
Applicant:Vansen Pharma
Ingredient:cefditoren pivoxil
Patents:0
Therapeutic Class:Antibacterials
Pharmacology for NDA: 021222
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 021222
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPECTRACEF cefditoren pivoxil TABLET;ORAL 021222 NDA Vansen Pharma Inc. 44004-801 E 44004-801-20
SPECTRACEF cefditoren pivoxil TABLET;ORAL 021222 NDA Vansen Pharma Inc. 44004-802 E 44004-802-20

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Aug 29, 2001TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG
Approval Date:Jul 21, 2008TE:RLD:No

Expired US Patents for NDA 021222

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vansen Pharma SPECTRACEF cefditoren pivoxil TABLET;ORAL 021222-002 Jul 21, 2008 ➤ Sign Up ➤ Sign Up
Vansen Pharma SPECTRACEF cefditoren pivoxil TABLET;ORAL 021222-001 Aug 29, 2001 ➤ Sign Up ➤ Sign Up
Vansen Pharma SPECTRACEF cefditoren pivoxil TABLET;ORAL 021222-001 Aug 29, 2001 ➤ Sign Up ➤ Sign Up
Vansen Pharma SPECTRACEF cefditoren pivoxil TABLET;ORAL 021222-001 Aug 29, 2001 ➤ Sign Up ➤ Sign Up
Vansen Pharma SPECTRACEF cefditoren pivoxil TABLET;ORAL 021222-002 Jul 21, 2008 ➤ 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:

Accenture
Fuji
QuintilesIMS
Mallinckrodt
Medtronic
UBS
US Army
Deloitte
Baxter

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