Application 090943

Type: ANDA
Sponsor: MYLAN

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 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
A090943-001	CAPECITABINE	CAPECITABINE	150MG	TABLET / ORAL	AB		2014-08-08
A090943-002	CAPECITABINE	CAPECITABINE	500MG	TABLET / ORAL	AB		2014-08-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090943-001	AB
A090943-002	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090943-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2014-08-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090943-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2014-08-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090943-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090943-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090943-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090943-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090943-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090943-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090943-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090943-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090943-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090943-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090943-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090943-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090943-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090943-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090943-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090943-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090943-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090943-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090943-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090943-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090943-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090943-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090943-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090943-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090943-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090943-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090943-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090943-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090943-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090943-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090943-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090943-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090943-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090943-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090943-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090943-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090943-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090943-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090943-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090943-002	AB	1	`bb7c543d1eb4…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
capecitabine	CAPECITABINE	NorthStar RxLLC	0b59e98c-5b34-4b93-90f6-20526f4d4f88	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	Aurobindo Pharma Limited	56441153-a1e5-4fdc-96d6-f21baa6b5fbe	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	Ascend Laboratories, LLC	06a88b03-6c06-4dae-b3bc-1e8dd81c9067	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
capecitabine	CAPECITABINE	Camber Pharmaceuticals, Inc.	3e7d6317-1439-4976-ae00-6f62619ec3dd	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	Golden State Medical Supply, Inc.	e28a5ef7-4731-f8ac-e053-2995a90a21bf	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
XELODA	CAPECITABINE	H2-Pharma, LLC	e702d84d-7162-4751-bf37-d724cc7e45a5	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPECITABINE
Capecitabine	CAPECITABINE	BluePoint Laboratories	88c5af84-900a-4372-b056-bfea70c129cf	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	Teva Pharmaceuticals USA, Inc.	5753679a-506c-4ac4-b8b2-b27c664d1d40	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
capecitabine	CAPECITABINE	Dr. Reddy's Laboratories Limited	007e3432-c8aa-2a76-52ba-c346924c08a7	2025-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	Quallent Pharmaceuticals Health LLC	d23f023a-ea62-4ac0-f615-d5d26d59526d	2025-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	Lifestar Pharma LLC	643a31d6-0e30-4602-a9b4-355fe944bfea	2025-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	American Health Packaging	2777b481-7d7f-461a-b5e0-c09ce2990c34	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	CivicaScript LLC	4ec2cfc1-e8ca-4109-8b90-1aab07cbab21	2025-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	Teyro Labs Private Limited	0c873e5b-51c2-4685-86c5-53f98563b093	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	Novadoz Pharmaceuticals LLC	29885ada-b743-419c-8f15-edd4247c76ca	2024-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
CAPECITABINE	CAPECITABINE	Accord Healthcare Inc.	8345d55e-ad02-4726-a04b-1a46e3337a4b	2024-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CAPECITABINE generic name: CAPECITABINE
Capecitabine	CAPECITABINE	Sun Pharmaceutical Industries, Inc.	e3b1a2b5-f1ce-45ea-afd8-68aac53665fa	2023-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
Capecitabine	CAPECITABINE	Cipla USA Inc.	2871c37d-5e55-437b-a434-fc86d845492a	2023-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Capecitabine generic name: CAPECITABINE
CAPECITABINE	CAPECITABINE	BluePoint Laboratories	bbb12406-ce02-3f31-e053-2995a90a0b16	2023-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CAPECITABINE generic name: CAPECITABINE
Capecitabine 500mg	CAPECITABINE	Armas Pharmaceuticals Inc.	f050d16c-ab76-489d-b92c-8c155b4e3f7c	2020-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPECITABINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2511	Capecitabine	capecitabine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2511	Capecitabine	capecitabine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2511	Capecitabine	capecitabine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2511	Capecitabine	capecitabine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2512	Capecitabine	capecitabine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2512	Capecitabine	capecitabine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2512	Capecitabine	capecitabine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2512	Capecitabine	capecitabine	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-510	Capecitabine	capecitabine	Mylan Institutional Inc.	ANDA	Current
51079-510	Capecitabine	capecitabine	Mylan Institutional Inc.	ANDA	Current
51079-510	Capecitabine	capecitabine	Mylan Institutional Inc.	ANDA	Current