Home Applications 216481 Application 216481
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE TABLET;ORAL 200MG No No 002 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE TABLET;ORAL 400MG No No 003 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE TABLET;ORAL 600MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A216481-001 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2026-08-05 A216481-002 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2026-08-05 A216481-003 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2026-08-05 A216481-004 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2026-08-05
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 2026-09-14 22:38:34 2026-08 A216481-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2026-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216481-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2026-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216481-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2026-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216481-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2026-08-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216481-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2026-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216481-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2026-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216481-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2026-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216481-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2026-08-05 caaa826d4ba7…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 75171 ORIG 2023-08-21