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Last Updated: September 27, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019880

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NDA 019880 describes PARAPLATIN, which is a drug marketed by Corden Pharma and Cordenpharma and is included in two NDAs. Additional details are available on the PARAPLATIN profile page.

The generic ingredient in PARAPLATIN is carboplatin. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
Summary for 019880
Tradename:PARAPLATIN
Applicant:Corden Pharma
Ingredient:carboplatin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019880
Paragraph IV (Patent) Challenges for 019880
Tradename Dosage Ingredient NDA Submissiondate
PARAPLATIN INJECTABLE;INJECTION carboplatin 019880

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 3, 1989TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 3, 1989TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 3, 1989TE:RLD:Yes

Expired US Patents for NDA 019880

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Corden Pharma PARAPLATIN carboplatin INJECTABLE;INJECTION 019880-001 Mar 3, 1989   Start Trial   Start Trial
Corden Pharma PARAPLATIN carboplatin INJECTABLE;INJECTION 019880-003 Mar 3, 1989   Start Trial   Start Trial
Corden Pharma PARAPLATIN carboplatin INJECTABLE;INJECTION 019880-002 Mar 3, 1989   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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