Home Applications 016608 Application 016608
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TEGRETOL CARBAMAZEPINE TABLET;ORAL 200MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N016608-001 TEGRETOL CARBAMAZEPINE 200MG TABLET / ORAL AB RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N016608-001 AB
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N016608-001 TEGRETOL 200MG TABLET / ORAL AB RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N016608-001 TEGRETOL 200MG TABLET / ORAL AB RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N016608-001 TEGRETOL 200MG TABLET / ORAL AB RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N016608-001 TEGRETOL 200MG TABLET / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 Tegretol CARBAMAZEPINE Novartis Pharmaceuticals Corporation 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 2026-08-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 016608 application number: NDA016608 ndc (product): 0078-0509
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0509 Tegretol carbamazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0509 Tegretol carbamazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0509 Tegretol carbamazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0509 Tegretol carbamazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0509 Tegretol carbamazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0509 Tegretol carbamazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0509 Tegretol carbamazepine Novartis Pharmaceuticals Corporation NDA Current 70518-1452 Tegretol carbamazepine REMEDYREPACK INC. NDA Current 70518-1452 Tegretol carbamazepine REMEDYREPACK INC. NDA Current