Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204354
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | 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 |
---|---|---|---|---|---|---|---|
11/24/2015 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204354Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204354Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/12/2023 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/12/2023 | SUPPL-6 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/12/2023 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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09/12/2023 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/12/2023 | SUPPL-1 | 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 |
---|---|---|---|---|---|
11/24/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204354Orig1s000lbl.pdf |
MESALAMINE
SUPPOSITORY;RECTAL; 1GM
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CANASA | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | Yes | AB | 021252 | ABBVIE |
MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 205654 | ACTAVIS MID ATLANTIC |
MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 208362 | AMRING PHARMS |
MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 213377 | ANNORA PHARMA |
MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 204354 | MYLAN |
MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 207448 | PHARM SOURCING |
MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 202065 | SANDOZ |
MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 208953 | ZYDUS PHARMS |