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General MedicationsORALStandard

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

Standard Dose
500MG;500MG;30MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) is listed in Drugs@FDA under application 206006 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE Form and strength CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG Sponsor RISING Submission history Latest submission status date: 2024-06-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) is listed in Drugs@FDA under application 206006 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE Form and strength CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG Sponsor RISING Submission history Latest submission status date: 2024-06-12 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.