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 44.

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 3 of 3 · 88 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	N020896-001	XELODA	150MG	TABLET / ORAL	AB	RLD	1998-04-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020896-002	XELODA	500MG	TABLET / ORAL	AB	RLD, RS	1998-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020896-001	XELODA	150MG	TABLET / ORAL	AB	RLD	1998-04-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020896-002	XELODA	500MG	TABLET / ORAL	AB	RLD, RS	1998-04-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020896-001	XELODA	150MG	TABLET / ORAL	AB	RLD	1998-04-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020896-002	XELODA	500MG	TABLET / ORAL	AB	RLD, RS	1998-04-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020896-001	XELODA	150MG	TABLET / ORAL		RLD	1998-04-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020896-002	XELODA	500MG	TABLET / ORAL		RLD	1998-04-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020896-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020896-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020896-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020896-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020896-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020896-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020896-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020896-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020896-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020896-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020896-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020896-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020896-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020896-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020896-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020896-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020896-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020896-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020896-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020896-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020896-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020896-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020896-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020896-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020896-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020896-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020896-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020896-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020896-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020896-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020896-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020896-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020896-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020896-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020896-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020896-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020896-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020896-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020896-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020896-002	AB	1	`87673890dc5c…`

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

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 · 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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83670	SUPPL	2025-10-06
83664	SUPPL	2025-10-06
73669	SUPPL	2023-03-03
73668	SUPPL	2023-03-03
73667	SUPPL	2023-03-03
73666	SUPPL	2023-03-03
73665	SUPPL	2023-03-03
73664	SUPPL	2023-03-03
73663	SUPPL	2023-03-03
73662	SUPPL	2023-03-03
72903	SUPPL	2022-12-15
72902	SUPPL	2022-12-15
72901	SUPPL	2022-12-15
72900	SUPPL	2022-12-15
72899	SUPPL	2022-12-15
72898	SUPPL	2022-12-15
72897	SUPPL	2022-12-15
72896	SUPPL	2022-12-15
72892	SUPPL	2022-12-15
72891	SUPPL	2022-12-15
72890	SUPPL	2022-12-15
72889	SUPPL	2022-12-15
72888	SUPPL	2022-12-15
72887	SUPPL	2022-12-15
72886	SUPPL	2022-12-15
72883	SUPPL	2022-12-14
67566	SUPPL	2021-05-20
67563	SUPPL	2021-05-20
57871	SUPPL	2020-04-17
57817	SUPPL	2019-02-27
46204	SUPPL	2016-12-19
46173	SUPPL	2016-12-15
13688	SUPPL	2015-03-24
3679	SUPPL	2015-03-24
13687	SUPPL	2015-03-05
26134	SUPPL	2015-03-03
35588	SUPPL	2014-10-21
26133	SUPPL	2014-10-21
3678	SUPPL	2013-12-16
35587	SUPPL	2013-12-11
51283	SUPPL	2011-07-01
35586	SUPPL	2011-02-09
3677	SUPPL	2011-02-09
51282	SUPPL	2008-05-07
51281	SUPPL	2007-01-19
3676	SUPPL	2005-06-16
35585	SUPPL	2005-06-15
51280	SUPPL	2005-03-16
13684	SUPPL	2003-04-25
13686	SUPPL	2003-03-26
3675	SUPPL	2003-03-26
41789	SUPPL	2001-09-07
35584	SUPPL	2001-09-07
26132	SUPPL	2001-09-07
21048	SUPPL	2001-09-07
13685	SUPPL	2001-09-07
3674	SUPPL	2001-09-07
41788	SUPPL	2001-04-30
41787	SUPPL	2001-04-30
3673	SUPPL	2001-04-30
3672	SUPPL	2001-04-30
41786	ORIG	1998-04-30
35583	ORIG	1998-04-30
3671	ORIG	1998-04-30
63883	ORIG	1900-01-01
63882	ORIG	1900-01-01
63881	ORIG	1900-01-01
52406	SUPPL	1900-01-01
52405	SUPPL	1900-01-01
52404	SUPPL	1900-01-01