Details for New Drug Application (NDA): 205383
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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 Action | X-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: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | 9.7GM/BOT | ||||
Approval Date: | Mar 26, 2015 | TE: | RLD: | No |
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