Application 021830
- Type
- NDA
- Sponsor
- APIL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ASACOL HD | MESALAMINE | TABLET, DELAYED RELEASE;ORAL | 800MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-5901 | Asacol HD | mesalamine | Allergan, Inc. | NDA | Current |
| 0023-5901 | Asacol HD | mesalamine | Allergan, Inc. | NDA | Current |
| 0023-5901 | Asacol HD | mesalamine | Allergan, Inc. | NDA | Current |
| 0023-5901 | Asacol HD | mesalamine | Allergan, Inc. | NDA | Current |
| 0023-5901 | Asacol HD | mesalamine | Allergan, Inc. | NDA | Current |
| 0023-5901 | Asacol HD | mesalamine | Allergan, Inc. | NDA | Current |
| 0023-5901 | Asacol HD | mesalamine | Allergan, Inc. | NDA | Current |
| 0023-5901 | Asacol HD | mesalamine | Allergan, Inc. | NDA | Current |
| 0430-0783 | ASACOL HD | mesalamine | Allergan, Inc. | NDA | Current |
| 50090-3497 | mesalamine | mesalamine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3497 | mesalamine | mesalamine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3497 | mesalamine | mesalamine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 59762-0117 | MESALAMINE | MESALAMINE | Greenstone LLC | NDA | Current |
| 60687-347 | mesalamine | mesalamine | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 68382-484 | mesalamine | mesalamine | Zydus Pharmaceuticals (USA) Inc. | NDA AUTHORIZED GENERIC | Current |
| 68382-649 | mesalamine | mesalamine | Zydus Pharmaceuticals (USA) Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72645 | SUPPL | 2022-11-17 |
| 72627 | SUPPL | 2022-11-17 |
| 69194 | SUPPL | 2021-11-02 |
| 69183 | SUPPL | 2021-11-02 |
| 64849 | SUPPL | 2020-10-06 |
| 64800 | SUPPL | 2020-10-02 |
| 64107 | SUPPL | 2020-07-28 |
| 53769 | SUPPL | 2018-04-23 |
| 53742 | SUPPL | 2018-04-19 |
| 49139 | SUPPL | 2017-07-28 |
| 49125 | SUPPL | 2017-07-28 |
| 16431 | SUPPL | 2016-05-06 |
| 6275 | SUPPL | 2016-05-06 |
| 37734 | SUPPL | 2013-10-22 |
| 28674 | SUPPL | 2013-10-21 |
| 37733 | SUPPL | 2012-05-14 |
| 28673 | SUPPL | 2010-05-28 |
| 21837 | ORIG | 2009-05-15 |
| 37732 | SUPPL | 2009-04-28 |
| 28672 | SUPPL | 2009-04-27 |
| 24220 | ORIG | 2008-07-17 |
| 37731 | ORIG | 2008-06-12 |
| 28671 | ORIG | 2008-06-03 |
| 51336 | SUPPL | 1900-01-01 |
| 51335 | SUPPL | 1900-01-01 |
| 51334 | SUPPL | 1900-01-01 |