Application 076274

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	TABLET;ORAL	EQ 75MG BASE	No	No
002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	TABLET;ORAL	EQ 300MG BASE	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
A076274-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17
A076274-002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076274-001	AB
A076274-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2014-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076274-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076274-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`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	A076274-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076274-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076274-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076274-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076274-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076274-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076274-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076274-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076274-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076274-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076274-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076274-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076274-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076274-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076274-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076274-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076274-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076274-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076274-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076274-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076274-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076274-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076274-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076274-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076274-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076274-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076274-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076274-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076274-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076274-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076274-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076274-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076274-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076274-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076274-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076274-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076274-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076274-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076274-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076274-002	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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel	CLOPIDOGREL BISULFATE	Cardinal Health 107, LLC	c03a895c-2d74-4d7f-891f-b752ce409b68	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076274 application number: ANDA076274
Clopidogrel	CLOPIDOGREL BISULFATE	Apotex Corp.	edae8df1-caf9-ff72-1304-5ae8b355f8e7	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076274 application number: ANDA076274 ndc (product): 60505-0253 ndc (product): 60505-3992 ndc (product): 60505-3532
Clopidogrel	CLOPIDOGREL BISULFATE	Major Pharmaceuticals	4cd07a3c-9673-4aa0-b76a-d79df2399ee1	2025-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076274 application number: ANDA076274 ndc (product): 0904-6467
Clopidogrel	CLOPIDOGREL BISULFATE	American Health Packaging	65ea4dc6-acb2-4609-9a4c-4866ef0ccb11	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076274 application number: ANDA076274 ndc (product): 68084-536 ndc (product): 68084-752
Clopidogrel	CLOPIDOGREL BISULFATE	Aphena Pharma Solutions - Tennessee, LLC	d49362ae-f78a-47d8-ac14-8262d621fcaa	2021-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076274 application number: ANDA076274 ndc (product): 71610-527

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8014	Clopidogrel	clopidogrel bisulfate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8014	Clopidogrel	clopidogrel bisulfate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8014	Clopidogrel	clopidogrel bisulfate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0904-6467	Clopidogrel	clopidogrel bisulfate	Major Pharmaceuticals	ANDA	Current
0904-6467	Clopidogrel	clopidogrel bisulfate	Major Pharmaceuticals	ANDA	Current
0904-6467	Clopidogrel	clopidogrel bisulfate	Major Pharmaceuticals	ANDA	Current
0904-6467	Clopidogrel	clopidogrel bisulfate	Major Pharmaceuticals	ANDA	Current
43353-269	clopidogrel bisulfate	clopidogrel bisulfate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-1301	Clopidogrel	clopidogrel bisulfate	A-S Medication Solutions	ANDA	Current
50090-1301	Clopidogrel	clopidogrel bisulfate	A-S Medication Solutions	ANDA	Current
50090-5330	Clopidogrel	clopidogrel bisulfate	A-S Medication Solutions	ANDA	Current
50090-5330	Clopidogrel	clopidogrel bisulfate	A-S Medication Solutions	ANDA	Current
51407-032	Clopidogrel	clopidogrel bisulfate	Golden State Medical Supply Inc.	ANDA	Current
51407-032	Clopidogrel	clopidogrel bisulfate	Golden State Medical Supply, Inc.	ANDA	Current
51407-032	Clopidogrel	clopidogrel bisulfate	Golden State Medical Supply, Inc.	ANDA	Current
51407-032	Clopidogrel	clopidogrel bisulfate	Golden State Medical Supply, Inc.	ANDA	Current
60429-301	clopidogrel bisulfate	clopidogrel bisulfate	Golden State Medical Supply, Inc.	ANDA	Current
60429-301	clopidogrel bisulfate	clopidogrel bisulfate	Golden State Medical Supply, Inc.	ANDA	Current
60429-301	clopidogrel bisulfate	clopidogrel bisulfate	Golden State Medical Supply, Inc.	ANDA	Current
60505-0253	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-0253	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-0253	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-0253	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-0253	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-0253	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3532	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3532	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3532	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3532	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3532	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3532	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3992	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3992	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3992	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3992	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3992	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
60505-3992	Clopidogrel	clopidogrel bisulfate	Apotex Corp.	ANDA	Current
62034-015	clopidogrel bisulfate	clopidogrel bisulfate	Blenheim Pharmacal, Inc.	ANDA	Current
68084-536	Clopidogrel	Clopidogrel Bisulfate	American Health Packaging	ANDA	Current
68084-536	Clopidogrel	Clopidogrel Bisulfate	American Health Packaging	ANDA	Current
68084-536	Clopidogrel	Clopidogrel Bisulfate	American Health Packaging	ANDA	Current
68084-752	Clopidogrel	Clopidogrel Bisulfate	American Health Packaging	ANDA	Current
68084-752	Clopidogrel	Clopidogrel Bisulfate	American Health Packaging	ANDA	Current
68084-752	Clopidogrel	Clopidogrel Bisulfate	American Health Packaging	ANDA	Current
70518-1383	Clopidogrel	clopidogrel bisulfate	REMEDYREPACK INC.	ANDA	Current
70518-1383	Clopidogrel	clopidogrel bisulfate	REMEDYREPACK INC.	ANDA	Current
70882-116	Clopidogrel	clopidogrel bisulfate	Cambridge Therapeutics Technologies, LLC	ANDA	Current
70882-123	Clopidogrel Kit	Clopidogrel Kit	Cambridge Therapeutics Technologies, LLC	ANDA	Current
71610-527	Clopidogrel	clopidogrel bisulfate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8885	ORIG	2012-05-18