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General MedicationsORALStandard

HYDROMORPHONE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE

Standard Dose
24MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: Prescription
  • Approval overview HYDROMORPHONE HYDROCHLORIDE is listed in Drugs@FDA under application 205629 (ANDA).
  • Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROMORPHONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 24MG Sponsor OSMOTICA PHARM US 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 205629 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROMORPHONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 24MG Sponsor OSMOTICA PHARM US 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.