Home Applications 020896 Application 020896
Type NDA
Sponsor HOFFMANN LA ROCHE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XELODA CAPECITABINE TABLET;ORAL 150MG Yes No 002 XELODA CAPECITABINE TABLET;ORAL 500MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020896-001 XELODA CAPECITABINE 150MG TABLET / ORAL RLD 1998-04-30 N020896-002 XELODA CAPECITABINE 500MG TABLET / ORAL RLD 1998-04-30
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 · 84 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 2026-08-18 06:07:40 2026-07 N020896-001 XELODA 150MG TABLET / ORAL RLD 1998-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020896-002 XELODA 500MG TABLET / ORAL RLD 1998-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020896-001 XELODA 150MG TABLET / ORAL RLD 1998-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020896-002 XELODA 500MG TABLET / ORAL RLD 1998-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 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 XELODA CAPECITABINE H2-Pharma, LLC e702d84d-7162-4751-bf37-d724cc7e45a5 2026-02-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020896 application number: NDA020896
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0004-1100 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1100 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1100 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1100 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1100 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1100 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1101 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1101 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1101 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1101 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1101 Xeloda capecitabine Genentech, Inc. NDA Current 0004-1101 Xeloda capecitabine Genentech, Inc. NDA Current 53808-0411 Xeloda capecitabine State of Florida DOH Central Pharmacy NDA Current