Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214585
Company: SUN PHARM
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MESALAMINE | MESALAMINE | 500MG | CAPSULE, EXTENDED 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 |
---|---|---|---|---|---|---|---|
05/11/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
Review (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214585Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214585Orig1s000.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214585Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/01/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
09/12/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
MESALAMINE
CAPSULE, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MESALAMINE | MESALAMINE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214585 | SUN PHARM |
PENTASA | MESALAMINE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020049 | TAKEDA PHARMS USA |