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General MedicationsORALGeneric

BALSALAZIDE DISODIUM

BALSALAZIDE DISODIUM

Standard Dose
1.1G
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview BALSALAZIDE DISODIUM is listed in Drugs@FDA under application 206909 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BALSALAZIDE DISODIUM Form and strength TABLET;ORAL - 1.1G Sponsor MYLAN PHARMS INC Submission history Latest submission status date: 2015-09-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview BALSALAZIDE DISODIUM is listed in Drugs@FDA under application 206909 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BALSALAZIDE DISODIUM Form and strength TABLET;ORAL - 1.1G Sponsor MYLAN PHARMS INC Submission history Latest submission status date: 2015-09-01 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.