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General MedicationsORALStandard

SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Standard Dose
12GM/PACKET;3.5GM/PACKET;10MG/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID is listed in Drugs@FDA under application 212789 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE Form and strength FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET Sponsor HETERO LABS LTD V Submission history Latest submission status date: 2022-07-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID is listed in Drugs@FDA under application 212789 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE Form and strength FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET Sponsor HETERO LABS LTD V Submission history Latest submission status date: 2022-07-18 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.