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FDA ANDA · ANDA205814

HYDROMORPHONE HYDROCHLORIDE

Sponsor: AUROLIFE PHARMA LLC

APPLICATION
ANDA205814
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-13
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 4MG · TABLET · ORAL
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 8MG · TABLET · ORAL
HYDROMORPHONE HYDROCHLORIDEPrescription
HYDROMORPHONE HYDROCHLORIDE 2MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 7AP
2024-10-31REMS · Supplement 6AP
2020-04-07Labeling · Supplement 3 · standardAP
2020-04-07Labeling · Supplement 1 · standardAP
2020-04-07Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 2AP
2016-05-13UNKNOWN · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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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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