Home Applications 217100 Application 217100
Type ANDA
Sponsor TORRENT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LAMOTRIGINE LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 25MG No No 002 LAMOTRIGINE LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 50MG No No 003 LAMOTRIGINE LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 100MG No No 004 LAMOTRIGINE LAMOTRIGINE TABLET, ORALLY DISINTEGRATING;ORAL 200MG 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 A217100-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 A217100-002 LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 A217100-003 LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 A217100-004 LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08
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 2026-02-19 14:30 UTC 2026-02 A217100-001 LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217100-002 LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217100-003 LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217100-004 LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217100-001 LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217100-002 LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217100-003 LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217100-004 LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2026-01-08 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LAMOTRIGINE LAMOTRIGINE Torrent Pharmaceuticals Limited 22225cc4-028e-43ad-8e1f-dcebdc244ecb 2026-07-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217100 application number: ANDA217100