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General MedicationsORALStandard

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Standard Dose
262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is listed in Drugs@FDA under application 202584 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE Form and strength TABLET, CHEWABLE, TABLET, CAPSULE;ORAL - 262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG Sponsor AILEX PHARMS LLC Submission history Latest submission status date: 2025-03-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is listed in Drugs@FDA under application 202584 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE Form and strength TABLET, CHEWABLE, TABLET, CAPSULE;ORAL - 262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG Sponsor AILEX PHARMS LLC Submission history Latest submission status date: 2025-03-31 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.