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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 205383


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NDA 205383 describes ORALTAG, which is a drug marketed by Interpharma Praha As and is included in one NDA. It is available from one supplier. Additional details are available on the ORALTAG profile page.

The generic ingredient in ORALTAG 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 205383
Tradename:ORALTAG
Applicant:Interpharma Praha As
Ingredient:iohexol
Patents:0
Pharmacology for NDA: 205383
Mechanism of ActionX-Ray Contrast Activity
Medical Subject Heading (MeSH) Categories for 205383
Suppliers and Packaging for NDA: 205383
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORALTAG iohexol FOR SOLUTION;ORAL 205383 NDA Interpharma Praha, a.s. 54702-501 54702-501-52 12 POUCH in 1 CASE (54702-501-52) / 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-51) / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21)
ORALTAG iohexol FOR SOLUTION;ORAL 205383 NDA Interpharma Praha, a.s. 54702-501 54702-501-62 25 POUCH in 1 CASE (54702-501-62) / 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-51) / 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength9.7GM/BOT
Approval Date:Mar 26, 2015TE:RLD:No

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