Home Applications 078069 Application 078069
Type ANDA
Sponsor BRECKENRIDGE PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG No No 002 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG No No 003 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG 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 A078069-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 A078069-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 A078069-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11
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 1 of 4 · 132 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 2026-10-15 13:18:30 2026-09 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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 2 of 2 · 21 matching rows.
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 2 of 2 · 89 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70518-2370 OXCARBAZEPINE OXCARBAZEPINE REMEDYREPACK INC. ANDA Current 70518-2370 OXCARBAZEPINE OXCARBAZEPINE REMEDYREPACK INC. ANDA Current 70518-2377 OXCARBAZEPINE OXCARBAZEPINE REMEDYREPACK INC. ANDA Current 70518-2377 OXCARBAZEPINE OXCARBAZEPINE REMEDYREPACK INC. ANDA Current 70518-2377 OXCARBAZEPINE OXCARBAZEPINE REMEDYREPACK INC. ANDA Current 70518-2377 OXCARBAZEPINE OXCARBAZEPINE REMEDYREPACK INC. ANDA Current 71335-0090 OXCARBAZEPINE OXCARBAZEPINE Bryant Ranch Prepack ANDA Current 71335-0090 OXCARBAZEPINE OXCARBAZEPINE Bryant Ranch Prepack ANDA Current 71335-0090 OXCARBAZEPINE OXCARBAZEPINE Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22619 ORIG 2011-02-15 44630 ORIG 2008-01-17