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FDA ANDA · ANDA205001
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: STRIDES PHARMA INTL
APPLICATION
ANDA205001
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-05
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 300MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 11AP
2025-12-22Labeling · Supplement 10 · standardAP
2025-12-22Labeling · Supplement 8 · standardAP
2024-10-31REMS · Supplement 9AP
2023-12-15Labeling · Supplement 7 · standardAP
2021-03-04Labeling · Supplement 6 · standardAP
2019-10-11Labeling · Supplement 5 · standardAP
2018-09-21Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 2AP
2017-04-13Labeling · Supplement 1 · 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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