FDA ANDA · ANDA213191
MESALAMINE
Sponsor: TEVA PHARMS INC
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APPLICATION
ANDA213191
TYPE
ANDA
ORIGINAL APPROVAL
2024-08-22
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 2 · standardAP
2024-08-22UNKNOWN · Original · standardAP
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