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FDA ANDA · ANDA202935
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Sponsor: STRIDES PHARMA INTL
APPLICATION
ANDA202935
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-15
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 21AP
2025-12-31Labeling · Supplement 19 · standardAP
2025-12-23Labeling · Supplement 17 · standardAP
2025-03-05Labeling · Supplement 15 · standardAP
2024-10-31REMS · Supplement 16AP
2023-12-15Labeling · Supplement 14 · standardAP
2021-03-04Labeling · Supplement 13 · standardAP
2019-10-11Labeling · Supplement 8 · standardAP
2018-09-20Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 3AP
2016-12-16Labeling · 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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