Home Applications 202593 Application 202593
Type ANDA
Sponsor ACCORD HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CAPECITABINE CAPECITABINE TABLET;ORAL 150MG No No 002 CAPECITABINE CAPECITABINE TABLET;ORAL 500MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202593-001 CAPECITABINE CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 A202593-002 CAPECITABINE CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 2026-09-14 22:38:34 2026-08 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 86 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.
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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16714-467 CAPECITABINE CAPECITABINE Northstar RxLLC ANDA Current 16714-467 CAPECITABINE CAPECITABINE Northstar RxLLC ANDA Current 16714-467 CAPECITABINE CAPECITABINE NORTHSTAR RXLLC ANDA Current 16714-467 CAPECITABINE CAPECITABINE NORTHSTAR RXLLC ANDA Current 16714-468 CAPECITABINE CAPECITABINE Northstar RxLLC ANDA Current 16714-468 CAPECITABINE CAPECITABINE Northstar RxLLC ANDA Current 16714-468 CAPECITABINE CAPECITABINE NORTHSTAR RXLLC ANDA Current 16714-468 CAPECITABINE CAPECITABINE NORTHSTAR RXLLC ANDA Current 16729-072 CAPECITABINE CAPECITABINE Accord Healthcare Inc. ANDA Current 16729-072 CAPECITABINE CAPECITABINE Accord Healthcare Inc. ANDA Current 16729-072 CAPECITABINE CAPECITABINE Accord Healthcare Inc. ANDA Current 16729-073 CAPECITABINE CAPECITABINE Accord Healthcare Inc. ANDA Current 16729-073 CAPECITABINE CAPECITABINE Accord Healthcare Inc. ANDA Current 16729-073 CAPECITABINE CAPECITABINE Accord Healthcare Inc. ANDA Current 68001-487 CAPECITABINE CAPECITABINE BluePoint Laboratories ANDA Current 68001-487 CAPECITABINE CAPECITABINE BluePoint Laboratories ANDA Current 68001-488 CAPECITABINE CAPECITABINE BluePoint Laboratories ANDA Current 68001-488 CAPECITABINE CAPECITABINE BluePoint Laboratories ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 10084 ORIG 2015-04-27