Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203286
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MESALAMINE | MESALAMINE | 800MG | TABLET, DELAYED RELEASE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/21/2017 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203286Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/203286Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/07/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/01/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/01/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/01/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/01/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2021 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/18/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2018 | SUPPL-2 | Labeling-Proprietary Name Change |
Label is not available on this site. |
||
| 06/26/2018 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |