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General MedicationsORAL SUSPENSIONGeneric

DOLUTEGRAVIR SODIUM

DOLUTEGRAVIR SODIUM

Standard Dose
10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: None (Tentative Approval)
Summary

Approval overview DOLUTEGRAVIR SODIUM is listed in Drugs@FDA under application 214566 (NDA).

Review priority: PRIORITY Marketing status: None (Tentative Approval) Active ingredient DOLUTEGRAVIR SODIUM Form and strength TABLET; ORAL SUSPENSION - 10MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2021-03-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview DOLUTEGRAVIR SODIUM is listed in Drugs@FDA under application 214566 (NDA). Review priority: PRIORITY Marketing status: None (Tentative Approval) Active ingredient DOLUTEGRAVIR SODIUM Form and strength TABLET; ORAL SUSPENSION - 10MG Sponsor MACLEODS PHARMS LTD Submission history Latest submission status date: 2021-03-16 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.