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Serving 500+ biopharmaceutical companies globally:

McKinsey
Fish and Richardson
Boehringer Ingelheim
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Farmers Insurance
Harvard Business School
Dow
Daiichi Sankyo
Cipla
Julphar

Generated: July 23, 2017

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. Nine suppliers are listed for this compound. Additional details are available on the cisplatin profile page.

Summary for NDA: 018057

Tradename:
3
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 018057

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hq Spclt Pharma
PLATINOL
cisplatin
INJECTABLE;INJECTION018057-001Approved Prior to Jan 1, 19825,562,925► Subscribe
Hq Spclt Pharma
PLATINOL
cisplatin
INJECTABLE;INJECTION018057-002Approved Prior to Jan 1, 19824,177,263► Subscribe
Hq Spclt Pharma
CISPLATIN
cisplatin
INJECTABLE;INJECTION018057-004Nov 8, 19884,177,263► Subscribe
Hq Spclt Pharma
PLATINOL
cisplatin
INJECTABLE;INJECTION018057-002Approved Prior to Jan 1, 19825,562,925► Subscribe
Hq Spclt Pharma
CISPLATIN
cisplatin
INJECTABLE;INJECTION018057-004Nov 8, 19885,562,925► Subscribe
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Serving 500+ biopharmaceutical companies globally:

McKinsey
McKesson
AstraZeneca
Johnson and Johnson
Farmers Insurance
Covington
Harvard Business School
Fish and Richardson
Medtronic
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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