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FDA ANDA · ANDA202142
PROLATE
oxycodone hydrochloride and acetaminophen
Sponsor: MIKART
APPLICATION
ANDA202142
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-27
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG/5ML, OXYCODONE HYDROCHLORIDE 10MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 12AP
2025-12-22Labeling · Supplement 11 · standardAP
2024-10-31REMS · Supplement 10AP
2024-03-15Labeling · Supplement 9 · standardAP
2024-01-09Labeling · Supplement 8 · standardAP
2021-03-04Labeling · Supplement 6 · standardAP
2020-05-29Manufacturing (CMC) · Supplement 5 · unknownAP
2019-10-08Labeling · Supplement 2 · 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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