Application 202928

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

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
A202928-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2014-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202928-001	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	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202928-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2014-02-10	`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	A202928-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202928-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202928-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202928-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202928-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202928-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202928-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202928-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202928-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202928-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202928-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202928-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202928-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202928-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202928-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202928-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202928-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202928-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202928-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202928-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202928-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202928-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202928-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202928-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202928-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202928-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202928-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202928-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202928-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202928-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202928-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202928-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202928-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202928-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202928-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202928-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202928-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202928-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202928-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202928-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel	CLOPIDOGREL	Redpharm Drug	55731d95-0c99-ff61-e063-6394a90a1ab5	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	NorthStar RxLLC	d176de1d-b1b3-4aa9-b783-d53f65a79e50	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928 ndc (product): 16714-052
Clopidogrel	CLOPIDOGREL	A-S Medication Solutions	02f0eaf8-0fc2-425d-8259-cef00156e25d	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928 ndc (product): 50090-5781
Clopidogrel	CLOPIDOGREL	A-S Medication Solutions	3aef6fd4-7160-4678-9362-ca76174bfd0e	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	A-S Medication Solutions	3c8c68ca-aa48-43f0-977d-2608e1666be4	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928
Clopidogrel	CLOPIDOGREL	Bryant Ranch Prepack	85df051d-0fa9-41b3-8862-9d6ca851a9cc	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928 ndc (product): 71335-0581
Clopidogrel	CLOPIDOGREL	Macleods Pharmaceuticals Limited	063cd1eb-98fd-422e-8145-bba04c497efe	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202928 application number: ANDA202928 ndc (product): 33342-060

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-052	Clopidogrel	Clopidogrel	NorthStar RxLLC	ANDA	Current
16714-052	Clopidogrel	Clopidogrel	NorthStar RxLLC	ANDA	Current
33342-060	Clopidogrel	Clopidogrel	Macleods Pharmaceuticals Limited	ANDA	Current
33342-060	Clopidogrel	Clopidogrel	Macleods Pharmaceuticals Limited	ANDA	Current
33342-060	Clopidogrel	Clopidogrel	Macleods Pharmaceuticals Limited	ANDA	Current
33342-060	Clopidogrel	Clopidogrel	Macleods Pharmaceuticals Limited	ANDA	Current
33342-060	Clopidogrel	Clopidogrel	Macleods Pharmaceuticals Limited	ANDA	Current
50090-5781	Clopidogrel	Clopidogrel	A-S Medication Solutions	ANDA	Current
68071-1578	Clopidogrel	Clopidogrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1578	Clopidogrel	Clopidogrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1578	Clopidogrel	Clopidogrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4031	Clopidogrel	Clopidogrel	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6324	Clopidogrel	Clopidogrel	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7645	Clopidogrel	Clopidogrel	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7645	Clopidogrel	Clopidogrel	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7645	Clopidogrel	Clopidogrel	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0400	Clopidogrel	Clopidogrel	REMEDYREPACK INC.	ANDA	Current
70518-0400	Clopidogrel	Clopidogrel	REMEDYREPACK INC.	ANDA	Current
70518-0400	Clopidogrel	Clopidogrel	REMEDYREPACK INC.	ANDA	Current
70518-0400	Clopidogrel	Clopidogrel	REMEDYREPACK INC.	ANDA	Current
70518-0400	Clopidogrel	Clopidogrel	REMEDYREPACK INC.	ANDA	Current
70518-0400	Clopidogrel	Clopidogrel	REMEDYREPACK INC.	ANDA	Current
70786-0060	Clopidogrel	Clopidogrel	Unit Dose Services	ANDA	Current
71335-0581	Clopidogrel	Clopidogrel	Bryant Ranch Prepack	ANDA	Current
71335-0581	Clopidogrel	Clopidogrel	Bryant Ranch Prepack	ANDA	Current
71335-0581	Clopidogrel	Clopidogrel	Bryant Ranch Prepack	ANDA	Current
76519-1016	Clopidogrel	Clopidogrel	H.J. Harkins Company Inc	ANDA	Current