Home Applications 218797 Application 218797
Type ANDA
Sponsor ZENARA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SAPROPTERIN DIHYDROCHLORIDE SAPROPTERIN DIHYDROCHLORIDE TABLET;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218797-001 SAPROPTERIN DIHYDROCHLORIDE SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2025-06-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218797-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218797-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2025-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218797-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2025-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218797-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2025-06-11 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218797-001 SAPROPTERIN DIHYDROCHLORIDE 100MG TABLET / ORAL AB 2025-06-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218797-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218797-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218797-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218797-001 AB 1 a50c72e98297…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.