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FDA ANDA · ANDA077311

HYDROMORPHONE HYDROCHLORIDE

Sponsor: NESHER PHARMS

APPLICATION
ANDA077311
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-09
LATEST ACTION
2005-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2005-11-09OriginalOther Important Information from FDAAP
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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