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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207873
Company: TEVA PHARMS USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESALAMINE MESALAMINE 400MG CAPSULE, DELAYED RELEASE;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/09/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207873Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/06/2025 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/20/2023 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/20/2023 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
09/20/2023 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

MESALAMINE

CAPSULE, DELAYED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MESALAMINE MESALAMINE 400MG CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 207873 TEVA PHARMS USA
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