Application 200483

Type: ANDA
Sponsor: HIKMA

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
A200483-001	CAPECITABINE	CAPECITABINE	150MG	TABLET / ORAL			2016-07-14
A200483-002	CAPECITABINE	CAPECITABINE	500MG	TABLET / ORAL			2016-07-14

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200483-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200483-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200483-001	CAPECITABINE	150MG	TABLET / ORAL		2016-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200483-002	CAPECITABINE	500MG	TABLET / ORAL		2016-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200483-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-07-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200483-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200483-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-07-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200483-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200483-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-07-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200483-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200483-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-07-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200483-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-07-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200483-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-07-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200483-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-07-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200483-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-07-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200483-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-07-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200483-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-07-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200483-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-07-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200483-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-07-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200483-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-07-14	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200483-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200483-002	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200483-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200483-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200483-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200483-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200483-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200483-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200483-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200483-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200483-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200483-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200483-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200483-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200483-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200483-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200483-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200483-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200483-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200483-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200483-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200483-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200483-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200483-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200483-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200483-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200483-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200483-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200483-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200483-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200483-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200483-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200483-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200483-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200483-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200483-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200483-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200483-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200483-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200483-002	AB	1	`1c564ffb4f44…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Capecitabine 150mg	CAPECITABINE	Armas Pharmaceuticals Inc.	7f555b6b-60db-45e2-a61e-537e57f43fdc	2020-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPECITABINE

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 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0271	Capecitabine	Capecitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0271	Capecitabine	Capecitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0271	Capecitabine	Capecitabine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0271	Capecitabine	Capecitabine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0271	Capecitabine	Capecitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0271	Capecitabine	Capecitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0271	Capecitabine	Capecitabine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0271	Capecitabine	Capecitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0271	Capecitabine	Capecitabine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0271	Capecitabine	Capecitabine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0272	Capecitabine	Capecitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0272	Capecitabine	Capecitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0272	Capecitabine	Capecitabine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0272	Capecitabine	Capecitabine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0272	Capecitabine	Capecitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0272	Capecitabine	Capecitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0272	Capecitabine	Capecitabine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0272	Capecitabine	Capecitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0272	Capecitabine	Capecitabine	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0272	Capecitabine	Capecitabine	West-Ward Pharmaceuticals Corp.	ANDA	Current
51407-095	Capecitabine	Capecitabine	Golden State Medical Supply Inc.	ANDA	Current
51407-095	Capecitabine	Capecitabine	Golden State Medical Supply, Inc.	ANDA	Current
51407-095	Capecitabine	Capecitabine	Golden State Medical Supply	ANDA	Current
51407-095	Capecitabine	Capecitabine	Golden State Medical Supply, Inc.	ANDA	Current
51407-095	Capecitabine	Capecitabine	Golden State Medical Supply, Inc.	ANDA	Current
51407-095	Capecitabine	Capecitabine	Golden State Medical Supply, Inc.	ANDA	Current
51407-096	Capecitabine	Capecitabine	Golden State Medical Supply Inc.	ANDA	Current
51407-096	Capecitabine	Capecitabine	Golden State Medical Supply, Inc.	ANDA	Current
51407-096	Capecitabine	Capecitabine	Golden State Medical Supply	ANDA	Current
51407-096	Capecitabine	Capecitabine	Golden State Medical Supply, Inc.	ANDA	Current
51407-096	Capecitabine	Capecitabine	Golden State Medical Supply, Inc.	ANDA	Current
51407-096	Capecitabine	Capecitabine	Golden State Medical Supply, Inc.	ANDA	Current