Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091640
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/05/2017 | ORIG-1 | Approval | Not Applicable |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/091640Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091640Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/091640Orig1_Approval_pkg.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/12/2024 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2023 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/01/2023 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/27/2022 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2023 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/07/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/091640Orig1s000lbl.pdf |
MESALAMINE
TABLET, DELAYED RELEASE;ORAL; 1.2GM
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LIALDA | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 022000 | TAKEDA PHARMS USA |
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 203817 | ACTAVIS LABS FL |
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 216334 | ANNORA PHARMA |
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 217337 | SINOTHERAPEUTICS INC |
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 211858 | SUN PHARM |
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091640 | ZYDUS PHARMS |