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FDA ANDA · ANDA204209
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE
Sponsor: PHARMOBEDIENT
APPLICATION
ANDA204209
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATEDiscontinued
ACETAMINOPHEN 325MG, CAFFEINE 30MG, DIHYDROCODEINE BITARTRATE 16MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 16AP
2025-12-22Labeling · Supplement 15 · standardAP
2025-04-14Labeling · Supplement 14 · standardAP
2023-12-15Labeling · Supplement 13 · standardAP
2021-03-04Labeling · Supplement 12 · standardAP
2019-10-07Labeling · Supplement 10 · standardAP
2018-11-09Labeling · Supplement 6 · standardAP
2018-09-20Labeling · Supplement 8 · standardAP
2018-09-18REMS · Supplement 7AP
2017-08-29Labeling · Supplement 5 · 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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