Drug application

SODIUM PHOSPHATES (SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE)

Drugs@FDA ANDA 218314 · AM REGENT

Key facts

Drug name SODIUM PHOSPHATES
Active ingredients SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Application type ANDA
Application number 218314
Company AM REGENT
Dosage forms SOLUTION, INTRAVENOUS
Strength 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Jun 21, 2024

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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