Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211858
Company: SUN PHARM
Company: SUN PHARM
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 |
---|---|---|---|---|---|---|---|
01/25/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/25/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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08/25/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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08/25/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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03/22/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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03/22/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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03/22/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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05/19/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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 |