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FDA ANDA · ANDA211610
ACETAMINOPHEN AND CODEINE PHOSPHATE
Sponsor: HIBROW HLTHCARE
APPLICATION
ANDA211610
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-27
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 15MG · TABLET · ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 8AP
2025-12-22Labeling · Supplement 7 · standardAP
2025-03-05Labeling · Supplement 5 · standardAP
2024-10-31REMS · Supplement 6AP
2023-12-15Labeling · Supplement 4 · standardAP
2023-12-15Labeling · Supplement 3 · standardAP
2023-11-30Labeling · Supplement 1 · standardAP
2019-06-27UNKNOWN · 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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