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Generated: January 21, 2018

DrugPatentWatch Database Preview

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 two suppliers. 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. Eleven 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 018057
Medical Subject Heading (MeSH) Categories for 018057
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:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.5MG/ML
Approval Date:Jul 18, 1984TE:RLD:Yes

Expired US Patents for NDA 018057

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

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Serving leading biopharmaceutical companies globally:

Medtronic
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Harvard Business School
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Fuji

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