APPLICATION
ANDA211278
TYPE
ANDA
ORIGINAL APPROVAL
2021-10-29
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFEN AND FAMOTIDINEDiscontinued
FAMOTIDINE 26.6MG, IBUPROFEN 800MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 4 · standardAP
2024-10-08Labeling · Supplement 1 · standardAP
2021-10-29UNKNOWN · 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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