General MedicationsORALStandard

HYDROMORPHONE HYDROCHLORIDE

Standard Dose

8MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview HYDROMORPHONE HYDROCHLORIDE is listed in Drugs@FDA under application 212133 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROMORPHONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 8MG Sponsor ASCENT PHARMS INC Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview HYDROMORPHONE HYDROCHLORIDE is listed in Drugs@FDA under application 212133 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROMORPHONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 8MG Sponsor ASCENT PHARMS INC Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.