APPLICATION
ANDA091640
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-05
LATEST ACTION
2024-01-12
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 1.2GM · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-01-12Labeling · Supplement 22 · standardAP
2023-08-07Labeling · Supplement 15 · standardAP
2023-08-07Labeling · Supplement 21 · standardAP
2023-08-07Labeling · Supplement 13 · standardAP
2023-08-07Labeling · Supplement 11 · standardAP
2023-08-07Labeling · Supplement 16 · standardAP
2023-08-07Labeling · Supplement 14 · standardAP
2023-08-07Labeling · Supplement 12 · standardAP
2023-05-01Labeling · Supplement 20 · standardAP
2022-07-27Labeling · Supplement 18 · standardAP
2020-05-19Labeling · Supplement 7 · standardAP
2020-05-19Labeling · Supplement 3 · standardAP
2020-05-19Labeling · Supplement 10 · standardAP
2020-05-19Labeling · Supplement 4 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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