Application 091649

Type: ANDA
Sponsor: TEVA PHARMS USA

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 1.

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
A091649-001	CAPECITABINE	CAPECITABINE	150MG	TABLET / ORAL	AB		2013-09-16
A091649-002	CAPECITABINE	CAPECITABINE	500MG	TABLET / ORAL	AB		2013-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091649-001	AB
A091649-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091649-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2013-09-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091649-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2013-09-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091649-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091649-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091649-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091649-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091649-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091649-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091649-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091649-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091649-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091649-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091649-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091649-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091649-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091649-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091649-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091649-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091649-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091649-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091649-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091649-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091649-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091649-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091649-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091649-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091649-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091649-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091649-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091649-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091649-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091649-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091649-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091649-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091649-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091649-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091649-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091649-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091649-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091649-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091649-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091649-002	AB	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Capecitabine	CAPECITABINE	Golden State Medical Supply, Inc.	e28a5ef7-4731-f8ac-e053-2995a90a21bf	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091649 application number: ANDA091649 ndc (product): 51407-639 ndc (product): 51407-640
Capecitabine	CAPECITABINE	Teva Pharmaceuticals USA, Inc.	5753679a-506c-4ac4-b8b2-b27c664d1d40	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091649 application number: ANDA091649 ndc (product): 0093-7474 ndc (product): 0093-7473
Capecitabine	CAPECITABINE	American Health Packaging	2777b481-7d7f-461a-b5e0-c09ce2990c34	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091649 application number: ANDA091649 ndc (product): 60687-149

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7473	Capecitabine	Capecitabine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7473	Capecitabine	Capecitabine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7473	Capecitabine	Capecitabine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7473	Capecitabine	Capecitabine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7474	Capecitabine	Capecitabine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7474	Capecitabine	Capecitabine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7474	Capecitabine	Capecitabine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7474	Capecitabine	Capecitabine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
51407-639	Capecitabine	Capecitabine	Golden State Medical Supply, Inc.	ANDA	Current
51407-640	Capecitabine	Capecitabine	Golden State Medical Supply, Inc.	ANDA	Current
60687-149	Capecitabine	Capecitabine	American Health Packaging	ANDA	Current
60687-149	Capecitabine	Capecitabine	American Health Packaging	ANDA	Current
60687-149	Capecitabine	Capecitabine	American Health Packaging	ANDA	Current
60687-149	Capecitabine	Capecitabine	American Health Packaging	ANDA	Current
60687-149	Capecitabine	Capecitabine	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18544	ORIG	2013-09-19
9349	ORIG	2013-09-19