General MedicationsORALStandard

TRAMADOL HYDROCHLORIDE

Standard Dose

300MG

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 - 300MG 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 - 300MG 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.