Product Details for NDA 019880
PARAPLATIN (CARBOPLATIN)
50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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; INJECTION
Strength: 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019880
Product Number: 001
Approval Date: Mar 3, 1989
Applicant Holder Full Name: CORDEN PHARMA LATINA SPA
Marketing Status: Discontinued
Patent and Exclusivity Information
PARAPLATIN (CARBOPLATIN)
Proprietary Name: PARAPLATIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019880
Product Number: 001
Approval Date: Mar 3, 1989
Applicant Holder Full Name: CORDEN PHARMA LATINA SPA
Marketing Status: Discontinued
Patent and Exclusivity Information
150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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; INJECTION
Strength: 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019880
Product Number: 002
Approval Date: Mar 3, 1989
Applicant Holder Full Name: CORDEN PHARMA LATINA SPA
Marketing Status: Discontinued
Patent and Exclusivity Information
PARAPLATIN (CARBOPLATIN)
Proprietary Name: PARAPLATIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 150MG/VIAL **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: N019880
Product Number: 002
Approval Date: Mar 3, 1989
Applicant Holder Full Name: CORDEN PHARMA LATINA SPA
Marketing Status: Discontinued
Patent and Exclusivity Information
450MG/VIAL **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; INJECTION
Strength: 450MG/VIAL **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: N019880
Product Number: 003
Approval Date: Mar 3, 1989
Applicant Holder Full Name: CORDEN PHARMA LATINA SPA
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PARAPLATIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 450MG/VIAL **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: N019880
Product Number: 003
Approval Date: Mar 3, 1989
Applicant Holder Full Name: CORDEN PHARMA LATINA SPA
Marketing Status: Discontinued
Patent and Exclusivity Information