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JAVYGTOR

Active substance: sapropterin

POWDER, FOR SOLUTION · SAPROPTERIN DIHYDROCHLORIDE 500 mg/1

United StatesActive

Marketing holder: Dr. Reddys Laboratories Inc

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 2
  • Kuvan
    sapropterin dihydrochloride
    EMEA/H/C/000943
    BioMarin International Limited
  • Sapropterin Dipharma
    sapropterin dihydrochloride
    EMEA/H/C/005646
    Dipharma Arzneimittel GmbH
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-cb24-7da4-b597-1decb974924c,01a1208c-d02e-7e65-8b83-476824c0ed93,01a1208d-1b66-7dae-9b8f-c326678e5474,01a1208e-3bca-7b92-bb55-1ed733a3a55f,01a1208e-4272-7698-8c42-613f9cc6da56;count=23 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
43598-162
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 43598-162 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 43598-162 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 43598-162 · Verified 2026-10-09 · open in source