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.
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 |
| Formulation / Manufacturing: | see details |
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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