Product Details for NDA 021473
CIPRO XR (CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE)
212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Proprietary Name: CIPRO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021473
Product Number: 001
Approval Date: Dec 13, 2002
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CIPRO XR (CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE)
Proprietary Name: CIPRO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021473
Product Number: 001
Approval Date: Dec 13, 2002
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Proprietary Name: CIPRO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021473
Product Number: 002
Approval Date: Aug 28, 2003
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CIPRO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021473
Product Number: 002
Approval Date: Aug 28, 2003
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information