Details for New Drug Application (NDA): 018057

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NDA 018057 describes PLATINOL-AQ, which is a drug marketed by Hq Spclt Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the PLATINOL-AQ profile page.

The generic ingredient in PLATINOL-AQ is cisplatin. There are fourteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cisplatin profile page.

Summary for 018057

Tradename:	PLATINOL-AQ
Applicant:	Hq Spclt Pharma
Ingredient:	cisplatin
Patents:	0

Pharmacology for NDA: 018057

Medical Subject Heading (MeSH) Categories for 018057

Antineoplastic Agents
Cross-Linking Reagents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 018057

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057	NDA	WG Critical Care, LLC	44567-509	44567-509-01	1 VIAL, MULTI-DOSE in 1 CARTON (44567-509-01) / 50 mL in 1 VIAL, MULTI-DOSE
CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057	NDA	WG Critical Care, LLC	44567-510	44567-510-01	1 VIAL, MULTI-DOSE in 1 CARTON (44567-510-01) / 100 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.5MG/ML
Approval Date:	Jul 18, 1984	TE:		RLD:	Yes

Expired US Patents for NDA 018057

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-004	Nov 8, 1988	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	PLATINOL-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984	⤷ Sign Up	⤷ Sign Up
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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