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Abbreviated New Drug Application (ANDA): 203817
Company: ACTAVIS LABS FL
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
03/23/2018 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203817Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/06/2021 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/29/2020 SUPPL-3 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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