Application 020049
- Type
- NDA
- Sponsor
- SHIRE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENTASA | MESALAMINE | CAPSULE, EXTENDED RELEASE;ORAL | 250MG | Yes | No |
| 002 | PENTASA | MESALAMINE | CAPSULE, EXTENDED RELEASE;ORAL | 500MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 54092-189 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-189 | Pentasa | mesalamine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-189 | Pentasa | mesalamine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-189 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-189 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-189 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-189 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-189 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-191 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-191 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-191 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-191 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-191 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-191 | Pentasa | mesalamine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-191 | Pentasa | mesalamine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-191 | Pentasa | mesalamine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 68151-4769 | Pentasa | mesalamine | Carilion Materials Management | NDA | Current |
| 69189-0189 | Pentasa | mesalamine | Avera McKennan Hospital | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79272 | SUPPL | 2024-08-02 |
| 79259 | SUPPL | 2024-07-31 |
| 75938 | SUPPL | 2023-10-25 |
| 75926 | SUPPL | 2023-10-25 |
| 72642 | SUPPL | 2022-11-17 |
| 72630 | SUPPL | 2022-11-17 |
| 69207 | SUPPL | 2021-11-02 |
| 69200 | SUPPL | 2021-11-02 |
| 67656 | SUPPL | 2021-06-02 |
| 67598 | SUPPL | 2021-05-26 |
| 65770 | SUPPL | 2020-12-28 |
| 65113 | SUPPL | 2020-11-02 |
| 64863 | SUPPL | 2020-10-07 |
| 64796 | SUPPL | 2020-10-02 |
| 59369 | SUPPL | 2019-07-18 |
| 59364 | SUPPL | 2019-07-17 |
| 54380 | SUPPL | 2018-05-31 |
| 54318 | SUPPL | 2018-05-24 |
| 49539 | SUPPL | 2017-08-25 |
| 49533 | SUPPL | 2017-08-24 |
| 49142 | SUPPL | 2017-07-31 |
| 49126 | SUPPL | 2017-07-28 |
| 41135 | SUPPL | 2015-11-18 |
| 21080 | SUPPL | 2015-08-10 |
| 34209 | SUPPL | 2015-08-07 |
| 21079 | SUPPL | 2013-12-17 |
| 12163 | SUPPL | 2013-12-17 |
| 34208 | SUPPL | 2013-07-30 |
| 21078 | SUPPL | 2013-07-26 |
| 41134 | SUPPL | 2007-11-19 |
| 21077 | SUPPL | 2007-07-05 |
| 1951 | SUPPL | 2006-07-03 |
| 1950 | SUPPL | 2004-07-14 |
| 41133 | SUPPL | 1999-09-10 |
| 21076 | SUPPL | 1999-09-10 |
| 12162 | SUPPL | 1999-09-10 |
| 41132 | ORIG | 1998-02-18 |