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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Accenture
Argus Health
Dow
AstraZeneca
Daiichi Sankyo
Healthtrust
Express Scripts
US Department of Justice
Cerilliant
US Army

Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020608

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NDA 020608 describes OMNIPAQUE 300, which is a drug marketed by Ge Healthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the OMNIPAQUE 300 profile page.

The generic ingredient in OMNIPAQUE 300 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.

Summary for 020608

Tradename:
3
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020608

Mechanism of ActionX-Ray Contrast Activity

Medical Subject Heading (MeSH) Categories for 020608

Suppliers and Packaging for NDA: 020608

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMNIPAQUE 350
iohexol
SOLUTION;INJECTION, ORAL 020608 NDA GE Healthcare 0407-1413 0407-1413-48 10 BOTTLE, PLASTIC in 1 BOX (0407-1413-48) > 500 mL in 1 BOTTLE, PLASTIC
OMNIPAQUE 350
iohexol
SOLUTION;INJECTION, ORAL 020608 NDA GE Healthcare 0407-1413 0407-1413-41 10 VIAL in 1 BOX (0407-1413-41) > 50 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTION, ORAL, RECTALStrength51.8%
Approval Date:Oct 24, 1995TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTION, ORAL, RECTALStrength64.7%
Approval Date:Oct 24, 1995TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTION, ORALStrength75.5%
Approval Date:Oct 24, 1995TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Healthtrust
US Army
Novartis
Citi
Federal Trade Commission
UBS
Queensland Health
McKinsey

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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