Application 205383
- Type
- NDA
- Sponsor
- INTERPHARMA PRAHA AS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ORALTAG | IOHEXOL | FOR SOLUTION;ORAL | 9.7GM/BOT | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54702-501 | ORALTAG | Iohexol | Interpharma Praha, a.s. | NDA | Current |
| 54702-501 | ORALTAG | Iohexol | Interpharma Praha, a.s. | NDA | Current |
| 54702-501 | ORALTAG | Iohexol | Interpharma Praha, a.s. | NDA | Current |
| 54702-501 | ORALTAG | Iohexol | Interpharma Praha, a.s. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 19639 | ORIG | 2015-04-28 |
| 24492 | ORIG | 2015-04-22 |
| 22985 | ORIG | 2015-04-22 |
| 10441 | ORIG | 2015-04-03 |
| 51206 | ORIG | 1900-01-01 |
| 51204 | ORIG | 1900-01-01 |
| 51203 | ORIG | 1900-01-01 |