Home Applications 216404 Application 216404
Type ANDA
Sponsor RICONPHARMA LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG No No 002 CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG No No 003 CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216404-001 CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2022-12-02 A216404-002 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2022-12-02 A216404-003 CARBAMAZEPINE CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE / ORAL AB 2022-12-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
Product history page 3 of 3 · 81 observed 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216404-003 CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE / ORAL AB 2022-12-02 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
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 Carbamazepine CARBAMAZEPINE Ingenus Pharmaceuticals, LLC de67de85-15b3-4c27-b604-d028ce3789d0 2025-10-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216404 application number: ANDA216404
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.