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General MedicationsORALStandard

TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE

Standard Dose
100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview TRAMADOL HYDROCHLORIDE is listed in Drugs@FDA under application 209404 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TRAMADOL HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 100MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2025-12-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview TRAMADOL HYDROCHLORIDE is listed in Drugs@FDA under application 209404 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TRAMADOL HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 100MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2025-12-29 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.