APPLICATION
ANDA210509
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-02
LATEST ACTION
2024-04-12
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
MESALAMINEDiscontinued
MESALAMINE 1GM · SUPPOSITORY · RECTAL
Approval history
2024-04-12Labeling · Supplement 8 · standardAP
2023-08-07Labeling · Supplement 7 · standardAP
2022-10-28Labeling · Supplement 6 · standardAP
2022-10-28Labeling · Supplement 2 · standardAP
2020-01-02UNKNOWN · 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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