Drug application

SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)

Drugs@FDA ANDA 215534 · ANNORA PHARMA

Key facts

Drug name SAPROPTERIN DIHYDROCHLORIDE
Active ingredients SAPROPTERIN DIHYDROCHLORIDE
Application type ANDA
Application number 215534
Company ANNORA PHARMA
Dosage forms TABLET, ORAL
Strength 100MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Aug 23, 2022

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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