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FDA ANDA · ANDA076723

HYDROMORPHONE HYDROCHLORIDE

Sponsor: MPP PHARMA

APPLICATION
ANDA076723
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-18
LATEST ACTION
2024-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROMORPHONE HYDROCHLORIDEDiscontinued
HYDROMORPHONE HYDROCHLORIDE 8MG · TABLET · ORAL

Approval history

2024-10-31REMS · Supplement 12AP
2020-04-15Labeling · Supplement 10 · standardAP
2020-04-15Labeling · Supplement 9 · standardAP
2020-04-15Labeling · Supplement 11 · standardAP
2020-04-15Labeling · Supplement 6 · standardAP
2018-09-18REMS · Supplement 8AP
2005-10-18Original — Other Important Information from FDA ↗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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