Application 021314
- Type
- NDA
- Sponsor
- EXALENZ BIOSCIENCE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IDKIT:HP | CITRIC ACID; UREA C-13 | FOR SOLUTION, TABLET, FOR SOLUTION;ORAL | N/A,4GM;75MG,N/A | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50402-100 | IDkit HP ONE | citric acid anhydrous and 13C urea | Exalenz Bioscience Ltd. | NDA | Current |
| 50402-100 | IDkit HP ONE | citric acid anhydrous and 13C urea | Exalenz Bioscience Ltd. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 5004 | SUPPL | 2016-07-12 |
| 15168 | SUPPL | 2014-11-18 |
| 27458 | SUPPL | 2014-10-29 |
| 21593 | ORIG | 2005-11-30 |
| 27457 | ORIG | 2004-06-07 |
| 36637 | ORIG | 2003-04-09 |