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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091640
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
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