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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019847

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CIPRO (CIPROFLOXACIN)
400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CIPROFLOXACIN
Proprietary Name: CIPRO
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019847
Product Number: 001
Approval Date: Dec 26, 1990
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
CIPRO (CIPROFLOXACIN)
200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CIPROFLOXACIN
Proprietary Name: CIPRO
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019847
Product Number: 002
Approval Date: Dec 26, 1990
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
CIPRO (CIPROFLOXACIN)
1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CIPROFLOXACIN
Proprietary Name: CIPRO
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019847
Product Number: 003
Approval Date: Dec 26, 1990
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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