APPLICATION
ANDA076751
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-17
LATEST ACTION
2007-05-22
ROUTE
RECTAL
DOSAGE FORM
ENEMA
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 4GM/60ML · ENEMA · RECTAL
Approval history
2007-05-22Manufacturing (CMC) · Supplement 5AP
2007-03-16Labeling · Supplement 6AP
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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