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General MedicationsORALGeneric

LEVATOL

PENBUTOLOL SULFATE

Standard Dose
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: UNKNOWN Marketing status: Discontinued
Summary

Approval overview LEVATOL is listed in Drugs@FDA under application 018976 (NDA).

Review priority: UNKNOWN Marketing status: Discontinued Active ingredient PENBUTOLOL SULFATE Form and strength TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ENDO OPERATIONS Submission history Latest submission status date: 2011-05-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview LEVATOL is listed in Drugs@FDA under application 018976 (NDA). Review priority: UNKNOWN Marketing status: Discontinued Active ingredient PENBUTOLOL SULFATE Form and strength TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ENDO OPERATIONS Submission history Latest submission status date: 2011-05-03 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: UNKNOWN

Interaction Notes

  • No interaction notes stored yet.