Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021222

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SPECTRACEF (CEFDITOREN PIVOXIL)
200MG
Marketing Status: Discontinued

Active Ingredient: CEFDITOREN PIVOXIL
Proprietary Name: SPECTRACEF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021222
Product Number: 001
Approval Date: Aug 29, 2001
Applicant Holder Full Name: VANSEN PHARMA
Marketing Status:  Discontinued
Patent and Exclusivity Information

SPECTRACEF (CEFDITOREN PIVOXIL)
400MG
Marketing Status: Discontinued

Active Ingredient: CEFDITOREN PIVOXIL
Proprietary Name: SPECTRACEF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021222
Product Number: 002
Approval Date: Jul 21, 2008
Applicant Holder Full Name: VANSEN PHARMA
Marketing Status:  Discontinued
Patent and Exclusivity Information