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General MedicationsINTRAVENOUSStandard

SODIUM PHENYLACETATE AND SODIUM BENZOATE

SODIUM BENZOATE; SODIUM PHENYLACETATE

Standard Dose
10%;10% (2GM/20ML; 2GM/20ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SODIUM PHENYLACETATE AND SODIUM BENZOATE is listed in Drugs@FDA under application 217526 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM BENZOATE; SODIUM PHENYLACETATE Form and strength SOLUTION;INTRAVENOUS - 10%;10% (2GM/20ML; 2GM/20ML) Sponsor NAVINTA LLC Submission history Latest submission status date: 2023-07-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview SODIUM PHENYLACETATE AND SODIUM BENZOATE is listed in Drugs@FDA under application 217526 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM BENZOATE; SODIUM PHENYLACETATE Form and strength SOLUTION;INTRAVENOUS - 10%;10% (2GM/20ML; 2GM/20ML) Sponsor NAVINTA LLC Submission history Latest submission status date: 2023-07-14 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.