Product Details for NDA 019537
CIPRO (CIPROFLOXACIN HYDROCHLORIDE)
EQ 250MG BASE
Marketing Status: Prescription
EQ 500MG BASE
Marketing Status: Prescription
EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 250MG BASE
Marketing Status: Prescription
Active Ingredient: CIPROFLOXACIN HYDROCHLORIDE
Proprietary Name: CIPRO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019537
Product Number: 002
Approval Date: Oct 22, 1987
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
CIPRO (CIPROFLOXACIN HYDROCHLORIDE)
Proprietary Name: CIPRO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019537
Product Number: 002
Approval Date: Oct 22, 1987
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 500MG BASE
Marketing Status: Prescription
Active Ingredient: CIPROFLOXACIN HYDROCHLORIDE
Proprietary Name: CIPRO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019537
Product Number: 003
Approval Date: Oct 22, 1987
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
CIPRO (CIPROFLOXACIN HYDROCHLORIDE)
Proprietary Name: CIPRO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019537
Product Number: 003
Approval Date: Oct 22, 1987
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CIPROFLOXACIN HYDROCHLORIDE
Proprietary Name: CIPRO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019537
Product Number: 004
Approval Date: Oct 22, 1987
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CIPRO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019537
Product Number: 004
Approval Date: Oct 22, 1987
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information