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General MedicationsORALStandard

ORPHENGESIC

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

Standard Dose
385MG;30MG;25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ORPHENGESIC is listed in Drugs@FDA under application 075141 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Form and strength TABLET;ORAL - 385MG;30MG;25MG Sponsor GALT PHARMS Submission history Latest submission status date: 2024-11-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview ORPHENGESIC is listed in Drugs@FDA under application 075141 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Form and strength TABLET;ORAL - 385MG;30MG;25MG Sponsor GALT PHARMS Submission history Latest submission status date: 2024-11-21 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.