APPLICATION
ANDA216814
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-15
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IBUPROFEN AND FAMOTIDINEPrescription
FAMOTIDINE 26.6MG, IBUPROFEN 800MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 2 · standardAP
2023-11-20Manufacturing (CMC) · Supplement 1 · unknownAP
2023-03-15UNKNOWN · 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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