← FDA DRUG APPROVALS
FDA ANDA · ANDA216592
PERIOD PILLS BY BIIKAY
acetaminophen, ibuprofen
Sponsor: GRANULES
APPLICATION
ANDA216592
TYPE
ANDA
ORIGINAL APPROVAL
2023-07-13
LATEST ACTION
2025-12-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
ACETAMINOPHEN AND IBUPROFENOver-the-counter
ACETAMINOPHEN 250MG, IBUPROFEN 125MG · TABLET · ORAL
Approval history
2025-12-17Labeling · Supplement 8 · standardAP
2025-10-01Labeling · Supplement 6 · standardAP
2024-03-27Labeling · Supplement 2 · standardAP
2023-07-13UNKNOWN · 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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