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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019537

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CIPRO (CIPROFLOXACIN HYDROCHLORIDE)
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)
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)
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: 001
Approval Date: Apr 8, 1996
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
CIPRO (CIPROFLOXACIN HYDROCHLORIDE)
EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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