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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:
OPTIMARK
Applicant:
Liebel-flarsheim
Ingredient:
gadoversetamide
Patents:0
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 0019-1177-11 10 SYRINGE, PLASTIC in 1 CARTON (0019-1177-11) > 10 mL in 1 SYRINGE, PLASTIC
OPTIMARK
gadoversetamide
INJECTABLE;INJECTION 020937 NDA Liebel-Flarsheim Company LLC 0019-1177 0019-1177-16 10 SYRINGE, PLASTIC in 1 CARTON (0019-1177-16) > 15 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;INJECTION020937-001Dec 8, 19995,130,120► subscribe
Liebel-flarsheim
OPTIMARK
gadoversetamide
INJECTABLE;INJECTION020937-003Dec 8, 19995,130,120► subscribe
Liebel-flarsheim
OPTIMARK
gadoversetamide
INJECTABLE;INJECTION020937-004Dec 8, 19995,130,120► subscribe
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