Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020452

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PARAPLATIN (CARBOPLATIN)
50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CARBOPLATIN
Proprietary Name: PARAPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020452
Product Number: 001
Approval Date: Jul 14, 2003
Applicant Holder Full Name: CORDENPHARMA
Marketing Status:  Discontinued
Patent and Exclusivity Information

PARAPLATIN (CARBOPLATIN)
150MG/15ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CARBOPLATIN
Proprietary Name: PARAPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 150MG/15ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020452
Product Number: 002
Approval Date: Jul 14, 2003
Applicant Holder Full Name: CORDENPHARMA
Marketing Status:  Discontinued
Patent and Exclusivity Information

PARAPLATIN (CARBOPLATIN)
450MG/45ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CARBOPLATIN
Proprietary Name: PARAPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 450MG/45ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020452
Product Number: 003
Approval Date: Jul 14, 2003
Applicant Holder Full Name: CORDENPHARMA
Marketing Status:  Discontinued
Patent and Exclusivity Information

PARAPLATIN (CARBOPLATIN)
600MG/60ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CARBOPLATIN
Proprietary Name: PARAPLATIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 600MG/60ML (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: N020452
Product Number: 004
Approval Date: Jan 15, 2004
Applicant Holder Full Name: CORDENPHARMA
Marketing Status:  Discontinued
Patent and Exclusivity Information