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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211858
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
03/22/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/22/2021 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/22/2021 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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 211858 SUN PHARM
MESALAMINE MESALAMINE 1.2GM TABLET, DELAYED RELEASE;ORAL Prescription No AB 091640 ZYDUS PHARMS
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