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General MedicationsORALGeneric

NYMALIZE

NIMODIPINE

Standard Dose
3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N/A Marketing status: Discontinued
Summary

Approval overview NYMALIZE is listed in Drugs@FDA under application 203340 (NDA).

Review priority: N/A Marketing status: Discontinued Active ingredient NIMODIPINE Form and strength SOLUTION;ORAL - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor AZURITY Submission history Latest submission status date: 2024-08-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview NYMALIZE is listed in Drugs@FDA under application 203340 (NDA). Review priority: N/A Marketing status: Discontinued Active ingredient NIMODIPINE Form and strength SOLUTION;ORAL - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor AZURITY Submission history Latest submission status date: 2024-08-28 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.
NYMALIZE (NIMODIPINE) | Drug Monograph | MedicHelpline