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Details for New Drug Application (NDA): 020316

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NDA 020316 describes OXILAN-350, which is a drug marketed by Guerbet and is included in one NDA. It is available from one supplier. Additional details are available on the OXILAN-350 profile page.

The generic ingredient in OXILAN-350 is ioxilan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ioxilan profile page.

Summary for NDA: 020316


Pharmacology for NDA: 020316

Mechanism of ActionX-Ray Contrast Activity

Suppliers and Packaging for NDA: 020316

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 020316 NDA Guerbet LLC 67684-1000 67684-1000-1 10 BOTTLE in 1 CARTON (67684-1000-1) > 50 mL in 1 BOTTLE
INJECTABLE;INJECTION 020316 NDA Guerbet LLC 67684-1000 67684-1000-2 10 BOTTLE in 1 CARTON (67684-1000-2) > 100 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength62%
Approval Date:Dec 21, 1995TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength73%
Approval Date:Dec 21, 1995TE:RLD:No

Expired Orange Book Patents for NDA: 020316

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
INJECTABLE;INJECTION020316-001Dec 21, 19954,954,348► Subscribe
INJECTABLE;INJECTION020316-002Dec 21, 19954,954,348► Subscribe
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