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General MedicationsOPHTHALMICStandard

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

Standard Dose
10,000 UNITS/ML;EQ 1MG BASE/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE is listed in Drugs@FDA under application 211572 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE Form and strength SOLUTION/DROPS;OPHTHALMIC - 10,000 UNITS/ML;EQ 1MG BASE/ML Sponsor SOMERSET THERAPS LLC Submission history Latest submission status date: 2024-08-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE is listed in Drugs@FDA under application 211572 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE Form and strength SOLUTION/DROPS;OPHTHALMIC - 10,000 UNITS/ML;EQ 1MG BASE/ML Sponsor SOMERSET THERAPS LLC Submission history Latest submission status date: 2024-08-05 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.