APPLICATION
ANDA202845
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-08
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DIFLUNISALPrescription
DIFLUNISAL 375MG · TABLET · ORAL
DIFLUNISALPrescription
DIFLUNISAL 500MG · TABLET · ORAL
DIFLUNISALPrescription
DIFLUNISAL 250MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 21 · standardAP
2024-08-16Manufacturing (CMC) · Supplement 19 · unknownAP
2021-04-28Labeling · Supplement 7 · standardAP
2016-05-09Labeling · Supplement 4 · standardAP
2012-03-08UNKNOWN · 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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