Application 076999

Type: ANDA
Sponsor: TEVA

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076999-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2012-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076999-001	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 2 · 42 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	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076999-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A076999-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076999-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076999-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076999-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076999-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076999-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076999-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076999-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076999-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076999-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076999-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076999-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076999-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076999-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076999-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076999-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076999-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076999-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076999-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076999-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076999-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076999-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076999-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076999-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076999-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076999-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076999-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076999-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076999-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076999-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076999-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076999-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076999-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076999-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076999-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076999-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076999-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076999-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076999-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076999-001	AB	1	`e64feba35796…`

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
Clopidogrel	CLOPIDOGREL	NuCare Pharmaceuticals,Inc.	5cdca9bd-7042-142a-e053-2991aa0a9ca6	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076999 application number: ANDA076999 ndc (product): 68071-4138
Clopidogrel	CLOPIDOGREL	Proficient Rx LP	25ed3120-7960-4e87-8422-de5c2026062c	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076999 application number: ANDA076999 ndc (product): 63187-362
Clopidogrel	CLOPIDOGREL	Teva Pharmaceuticals USA, Inc.	bc747f6d-f52c-4dcb-bda5-2d0a9f954147	2019-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076999 application number: ANDA076999 ndc (product): 0093-7314

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7314	Clopidogrel	Clopidogrel	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7314	Clopidogrel	Clopidogrel	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7314	Clopidogrel	Clopidogrel	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7314	Clopidogrel	Clopidogrel	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7314	Clopidogrel	Clopidogrel	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7314	Clopidogrel	Clopidogrel	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0615-7719	Clopidogrel	Clopidogrel	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
53808-1025	Clopidogrel	Clopidogrel	State of Florida DOH Central Pharmacy	ANDA	Current
54458-888	Clopidogrel	Clopidogrel	International Laboratories, LLC	ANDA	Current
54458-888	Clopidogrel	Clopidogrel	International Laboratories, LLC	ANDA	Current
63187-362	Clopidogrel	Clopidogrel	Proficient Rx LP	ANDA	Current
63187-362	Clopidogrel	Clopidogrel	Proficient Rx LP	ANDA	Current
63629-4728	Clopidogrel	Clopidogrel	Bryant Ranch Prepack	ANDA	Current
63629-4728	Clopidogrel	Clopidogrel	Bryant Ranch Prepack	ANDA	Current
66116-494	Clopidogrel	Clopidogrel	MedVantx, Inc.	ANDA	Current
68071-4138	Clopidogrel	Clopidogrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4138	Clopidogrel	Clopidogrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4138	Clopidogrel	Clopidogrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68645-430	Clopidogrel	Clopidogrel	Legacy Pharmaceutical Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31184	ORIG	2012-05-18