Application 090844

Type: ANDA
Sponsor: TORRENT 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
A090844-001	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
A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090844-001	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	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090844-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090844-001	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	A090844-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090844-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090844-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090844-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090844-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090844-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090844-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090844-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090844-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090844-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090844-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090844-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090844-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090844-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090844-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090844-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090844-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090844-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090844-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090844-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090844-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090844-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090844-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090844-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090844-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090844-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090844-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090844-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090844-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090844-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090844-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090844-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090844-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090844-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090844-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090844-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090844-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090844-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090844-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090844-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel Bisulfate	CLOPIDOGREL BISULFATE	PD-Rx Pharmaceuticals, Inc.	03bec9ad-cd22-44d3-9b82-2796157de1d1	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090844 application number: ANDA090844 ndc (product): 43063-371
Clopidogrel	CLOPIDOGREL	Torrent Pharmaceuticals Limited	ae07b785-b522-41c6-b27c-24c4d5cd814d	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090844 application number: ANDA090844 ndc (product): 13668-141

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6294	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Major Pharmaceuticals	ANDA	Current
0904-6294	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Major Pharmaceuticals	ANDA	Current
0904-6294	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Major Pharmaceuticals	ANDA	Current
0904-6294	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Major Pharmaceuticals	ANDA	Current
13668-141	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-141	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-141	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-141	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-141	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-141	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-141	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-141	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-141	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Torrent Pharmaceuticals Limited	ANDA	Current
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-371	Clopidogrel Bisulfate	Clopidogrel Bisulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55154-3376	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Cardinal Health	ANDA	Current
55154-3376	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Cardinal Health	ANDA	Current
55154-3376	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Cardinal Health	ANDA	Current
55154-3376	Clopidogrel Bisulfate	Clopidogrel Bisulfate	Cardinal Health	ANDA	Current
70518-0195	Clopidogrel Bisulfate	Clopidogrel Bisulfate	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31502	ORIG	2012-05-18