Application 203441
- Type
- NDA
- Sponsor
- NPS PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GATTEX KIT | TEDUGLUTIDE RECOMBINANT | POWDER;SUBCUTANEOUS | 5MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68875-0101 | Gattex | teduglutide | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 68875-0101 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0101 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0101 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0101 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0101 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0102 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0102 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0102 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0102 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0102 | Gattex | teduglutide | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 68875-0102 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0103 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0103 | Gattex | teduglutide | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 68875-0103 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0103 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0103 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
| 68875-0103 | Gattex | teduglutide | Shire-NPS Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83314 | SUPPL | 2025-09-09 |
| 83313 | SUPPL | 2025-09-09 |
| 83304 | SUPPL | 2025-09-08 |
| 83100 | SUPPL | 2025-08-15 |
| 79680 | SUPPL | 2024-09-23 |
| 77599 | SUPPL | 2024-02-22 |
| 77593 | SUPPL | 2024-02-22 |
| 76359 | ORIG | 2023-11-06 |
| 73324 | SUPPL | 2023-01-30 |
| 73285 | SUPPL | 2023-01-25 |
| 66211 | SUPPL | 2021-02-16 |
| 66056 | SUPPL | 2021-02-02 |
| 66040 | SUPPL | 2021-02-01 |
| 66039 | SUPPL | 2021-02-01 |
| 63967 | SUPPL | 2020-07-20 |
| 58801 | SUPPL | 2019-05-21 |
| 58792 | SUPPL | 2019-05-20 |
| 58791 | SUPPL | 2019-05-20 |
| 56937 | SUPPL | 2018-12-21 |
| 56787 | SUPPL | 2018-12-19 |
| 56786 | SUPPL | 2018-12-19 |
| 56358 | SUPPL | 2018-11-08 |
| 47725 | APPL | 2017-03-28 |
| 47685 | SUPPL | 2017-03-24 |
| 10216 | SUPPL | 2016-05-31 |
| 43433 | SUPPL | 2016-02-03 |
| 19470 | SUPPL | 2014-06-30 |
| 32424 | SUPPL | 2014-06-27 |
| 44883 | ORIG | 2013-01-25 |
| 43432 | ORIG | 2013-01-25 |
| 23500 | ORIG | 2013-01-03 |
| 32423 | ORIG | 2012-12-27 |
| 19469 | ORIG | 2012-12-27 |
| 66909 | ORIG | 1900-01-01 |
| 64185 | ORIG | 1900-01-01 |
| 64184 | ORIG | 1900-01-01 |
| 64183 | ORIG | 1900-01-01 |
| 63264 | SUPPL | 1900-01-01 |
| 63263 | SUPPL | 1900-01-01 |