Home Applications 217638 Application 217638
Type ANDA
Sponsor FOSUN WANBANG Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE No No 002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE No No 003 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE No No 004 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217638-001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-12 A217638-002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-12 A217638-003 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-12 A217638-004 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 2026-08-01 22:54:32 2026-06 A217638-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-12 a50c72e98297…2026-08-01 22:54:32 2026-06 A217638-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-12 a50c72e98297…2026-08-01 22:54:32 2026-06 A217638-003 GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-12 a50c72e98297…2026-08-01 22:54:32 2026-06 A217638-004 GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2024-06-12 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.