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General MedicationsORALStandard

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Standard Dose
140MG;125MG;125MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is listed in Drugs@FDA under application 217511 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 140MG;125MG;125MG Sponsor INGENUS PHARMS LLC Submission history Latest submission status date: 2023-07-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is listed in Drugs@FDA under application 217511 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 140MG;125MG;125MG Sponsor INGENUS PHARMS LLC Submission history Latest submission status date: 2023-07-03 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.