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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. Two suppliers are listed for this compound. Additional details are available on the iohexol profile page.

Summary for NDA: 205383

Tradename:
ORALTAG
Applicant:
Interpharma Praha As
Ingredient:
iohexol
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 205383

Mechanism of ActionX-Ray Contrast Activity

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)

Summary for product number 001

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


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