Details for New Drug Application (NDA): 020452

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NDA 020452 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. Eleven suppliers are listed for this compound. Additional details are available on the carboplatin profile page.

Summary for 020452

Tradename:	PARAPLATIN
Applicant:	Cordenpharma
Ingredient:	carboplatin
Patents:	0

Medical Subject Heading (MeSH) Categories for 020452

Antineoplastic Agents
Cross-Linking Reagents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 14, 2003	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	150MG/15ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 14, 2003	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	450MG/45ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 14, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 020452

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-001	Jul 14, 2003	4,657,927*PED	⤷ Subscribe
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-004	Jan 15, 2004	4,657,927*PED	⤷ Subscribe
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-003	Jul 14, 2003	4,657,927*PED	⤷ Subscribe
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-002	Jul 14, 2003	4,657,927*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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