Product Details for ANDA 065166
CEFUROXIME AXETIL (CEFUROXIME AXETIL)
EQ 125MG BASE
Marketing Status: Prescription
EQ 250MG BASE
Marketing Status: Prescription
EQ 500MG BASE
Marketing Status: Prescription
EQ 125MG BASE
Marketing Status: Prescription
Active Ingredient: CEFUROXIME AXETIL
Proprietary Name: CEFUROXIME AXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 125MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065166
Product Number: 001
Approval Date: Jul 29, 2005
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CEFUROXIME AXETIL (CEFUROXIME AXETIL)
Proprietary Name: CEFUROXIME AXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 125MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065166
Product Number: 001
Approval Date: Jul 29, 2005
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 250MG BASE
Marketing Status: Prescription
Active Ingredient: CEFUROXIME AXETIL
Proprietary Name: CEFUROXIME AXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065166
Product Number: 002
Approval Date: Jul 29, 2005
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CEFUROXIME AXETIL (CEFUROXIME AXETIL)
Proprietary Name: CEFUROXIME AXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065166
Product Number: 002
Approval Date: Jul 29, 2005
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 500MG BASE
Marketing Status: Prescription
Active Ingredient: CEFUROXIME AXETIL
Proprietary Name: CEFUROXIME AXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065166
Product Number: 003
Approval Date: Jul 29, 2005
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: CEFUROXIME AXETIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065166
Product Number: 003
Approval Date: Jul 29, 2005
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Prescription
Patent and Exclusivity Information