APPLICATION
ANDA211858
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-25
LATEST ACTION
2023-08-25
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 1.2GM · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-08-25Labeling · Supplement 16 · standardAP
2023-08-25Labeling · Supplement 12 · standardAP
2023-08-25Labeling · Supplement 11 · standardAP
2021-03-22Labeling · Supplement 6 · standardAP
2021-03-22Labeling · Supplement 2 · standardAP
2021-03-22Labeling · Supplement 5 · standardAP
2020-05-19Labeling · Supplement 1 · standardAP
2019-01-25UNKNOWN · Original · 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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