APPLICATION
ANDA203574
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-20
LATEST ACTION
2020-05-20
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
MESALAMINEDiscontinued
MESALAMINE 1.2GM · TABLET, DELAYED RELEASE · ORAL
Approval history
2020-05-20Labeling · Supplement 1 · standardAP
2018-11-20UNKNOWN · OriginalAP
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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