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General MedicationsORALStandard

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Standard Dose
325MG;37.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is listed in Drugs@FDA under application 207152 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE Form and strength TABLET;ORAL - 325MG;37.5MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2025-12-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN is listed in Drugs@FDA under application 207152 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE Form and strength TABLET;ORAL - 325MG;37.5MG Sponsor AUROBINDO PHARMA 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.
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE) | Drug Monograph | MedicHelpline