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General MedicationsORALGeneric

PREVPAC (COPACKAGED)

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

Standard Dose
500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview PREVPAC (COPACKAGED) is listed in Drugs@FDA under application 050757 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE Form and strength CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2018-06-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview PREVPAC (COPACKAGED) is listed in Drugs@FDA under application 050757 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE Form and strength CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2018-06-07 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.