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FDA ANDA · ANDA076758

OXYCODONE HYDROCHLORIDE

Sponsor: SPECGX LLC

APPLICATION
ANDA076758
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 20MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 15MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 30MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 32AP
2024-10-31REMS · Supplement 28AP
2021-09-21Labeling · Supplement 18 · standardAP
2021-09-21Labeling · Supplement 16 · standardAP
2021-09-21Labeling · Supplement 22 · standardAP
2021-09-21Labeling · Supplement 20 · standardAP
2018-09-18REMS · Supplement 17AP
2010-07-14Labeling · Supplement 7AP
2008-01-29Labeling · Supplement 3AP
2004-06-30Original — REMS ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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