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Serving 500+ biopharmaceutical companies globally:

McKesson
Fish and Richardson
Fuji
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Express Scripts
US Army
Cantor Fitzgerald
Queensland Health
Medtronic
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Generated: July 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020937

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NDA 020937 describes OPTIMARK, which is a drug marketed by Liebel-flarsheim and is included in three NDAs. It is available from one supplier. Additional details are available on the OPTIMARK profile page.

The generic ingredient in OPTIMARK is gadoversetamide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadoversetamide profile page.

Summary for NDA: 020937

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

Pharmacology for NDA: 020937

Suppliers and Packaging for NDA: 020937

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPTIMARK
gadoversetamide
INJECTABLE;INJECTION 020937 NDA Liebel-Flarsheim Company LLC 0019-1177 0019-1177-50 5 BOTTLE, GLASS in 1 CARTON (0019-1177-50) > 50 mL in 1 BOTTLE, GLASS
OPTIMARK
gadoversetamide
INJECTABLE;INJECTION 020937 NDA Liebel-Flarsheim Company LLC 0019-1177 0019-1177-11 10 SYRINGE, PLASTIC in 1 CARTON (0019-1177-11) > 10 mL in 1 SYRINGE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1654.5MG/5ML (330.9MG/ML)
Approval Date:Dec 8, 1999TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3309MG/10ML (330.9MG/ML)
Approval Date:Dec 8, 1999TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4963.5MG/15ML (330.9MG/ML)
Approval Date:Dec 8, 1999TE:RLD:Yes

Expired Orange Book Patents for NDA: 020937

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Liebel-flarsheim
OPTIMARK
gadoversetamide
INJECTABLE;INJECTION020937-003Dec 8, 1999► Subscribe► Subscribe
Liebel-flarsheim
OPTIMARK
gadoversetamide
INJECTABLE;INJECTION020937-001Dec 8, 1999► Subscribe► Subscribe
Liebel-flarsheim
OPTIMARK
gadoversetamide
INJECTABLE;INJECTION020937-002Dec 8, 1999► Subscribe► Subscribe
Liebel-flarsheim
OPTIMARK
gadoversetamide
INJECTABLE;INJECTION020937-003Dec 8, 1999► Subscribe► Subscribe
Liebel-flarsheim
OPTIMARK
gadoversetamide
INJECTABLE;INJECTION020937-002Dec 8, 1999► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Cipla
Farmers Insurance
McKinsey
Mallinckrodt
Argus Health
Citi
Cantor Fitzgerald
Accenture
Chubb

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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