Application 076273

Type: ANDA
Sponsor: DR REDDYS LABS 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076273-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2008-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076273-001	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 · 41 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	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076273-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2008-01-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A076273-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076273-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076273-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076273-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076273-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076273-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076273-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076273-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076273-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076273-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076273-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076273-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076273-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076273-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076273-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076273-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076273-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076273-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076273-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076273-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076273-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076273-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076273-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076273-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076273-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076273-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076273-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076273-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076273-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076273-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076273-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076273-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076273-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076273-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076273-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076273-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076273-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076273-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076273-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076273-001	AB	1	`cb3db0bc1861…`

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	Quallent Pharmaceuticals Health LLC	333c7992-d481-b7d4-404f-9a49c85b6331	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076273 application number: ANDA076273 ndc (product): 82009-021
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Dr.Reddy's Laboratories Limited	b5aa951f-72de-bea1-98a2-a4085c64a361	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076273 application number: ANDA076273 ndc (product): 55111-196

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-1002	Clopidogrel bisulfate	Clopidogrel bisulfate	State of Florida DOH Central Pharmacy	ANDA	Current
55111-196	Clopidogrel bisulfate	Clopidogrel bisulfate	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-196	Clopidogrel bisulfate	Clopidogrel bisulfate	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-196	Clopidogrel bisulfate	Clopidogrel bisulfate	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-196	Clopidogrel bisulfate	Clopidogrel bisulfate	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-196	Clopidogrel bisulfate	Clopidogrel bisulfate	Dr.Reddy's Laboratories Limited	ANDA	Current
67046-099	Clopidogrel bisulfate	Clopidogrel bisulfate	Contract Pharmacy Services-PA	ANDA	Current
68151-3118	Clopidogrel bisulfate	Clopidogrel bisulfate	Carilion Materials Management	ANDA	Current
68788-9785	Clopidogrel bisulfate	Clopidogrel bisulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9785	Clopidogrel bisulfate	Clopidogrel bisulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0717	Clopidogrel bisulfate	Clopidogrel bisulfate	REMEDYREPACK INC.	ANDA	Current
70518-0717	Clopidogrel bisulfate	Clopidogrel bisulfate	REMEDYREPACK INC.	ANDA	Current
82009-021	Clopidogrel bisulfate	Clopidogrel bisulfate	Quallent Pharmaceuticals Health LLC	ANDA	Current
82009-021	Clopidogrel bisulfate	Clopidogrel bisulfate	Quallent Pharmaceuticals Health LLC	ANDA	Current