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General MedicationsINJECTIONGeneric

INDOCIN

INDOMETHACIN SODIUM

Standard Dose
EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 INDOCIN is listed in Drugs@FDA under application 018878 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient INDOMETHACIN SODIUM Form and strength INJECTABLE;INJECTION - EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor RECORDATI RARE Submission history Latest submission status date: 2021-03-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview INDOCIN is listed in Drugs@FDA under application 018878 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient INDOMETHACIN SODIUM Form and strength INJECTABLE;INJECTION - EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor RECORDATI RARE Submission history Latest submission status date: 2021-03-26 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.