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General MedicationsORALGeneric

CETYLEV

ACETYLCYSTEINE

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

Approval overview CETYLEV is listed in Drugs@FDA under application 207916 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETYLCYSTEINE Form and strength TABLET, EFFERVESCENT;ORAL - 500MG Sponsor ARBOR PHARMS LLC Submission history Latest submission status date: 2018-03-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview CETYLEV is listed in Drugs@FDA under application 207916 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETYLCYSTEINE Form and strength TABLET, EFFERVESCENT;ORAL - 500MG Sponsor ARBOR PHARMS LLC Submission history Latest submission status date: 2018-03-16 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.