Home Applications 219997 Application 219997
Type ANDA
Sponsor DIFGEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MESALAMINE MESALAMINE CAPSULE, EXTENDED RELEASE;ORAL 250MG No No 002 MESALAMINE MESALAMINE CAPSULE, EXTENDED RELEASE;ORAL 500MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219997-001 MESALAMINE MESALAMINE 250MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 A219997-002 MESALAMINE MESALAMINE 500MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-08-18 06:07:40 2026-07 A219997-001 MESALAMINE 250MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219997-002 MESALAMINE 500MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219997-001 MESALAMINE 250MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219997-002 MESALAMINE 500MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A219997-001 AB 1 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219997-002 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219997-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219997-002 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.