FDA ANDA · ANDA203286
MESALAMINE
Sponsor: ZYDUS PHARMS
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APPLICATION
ANDA203286
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-21
LATEST ACTION
2026-10-15
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 800MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-10-15Labeling · Supplement 18 · standardAP
2023-11-07Labeling · Supplement 14 · standardAP
2023-03-01Labeling · Supplement 8 · standardAP
2023-03-01Labeling · Supplement 12 · standardAP
2023-03-01Labeling · Supplement 10 · standardAP
2023-03-01Labeling · Supplement 11 · standardAP
2021-11-18Labeling · Supplement 4 · standardAP
2021-11-18Labeling · Supplement 7 · standardAP
2021-11-18Labeling · Supplement 3 · standardAP
2018-06-26Labeling · Supplement 2 · standardAP
2018-06-26Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →