Application 091023

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	TABLET;ORAL	EQ 300MG BASE	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091023-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2012-05-17
A091023-002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2024-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091023-001	AB
A091023-002	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 2 · 55 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	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091023-002	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2024-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091023-001	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-05-17	`ea99ee380514…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 55 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	A091023-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091023-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091023-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091023-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091023-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091023-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091023-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091023-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091023-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091023-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091023-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091023-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091023-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091023-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091023-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091023-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091023-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091023-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091023-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091023-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091023-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091023-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091023-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091023-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091023-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091023-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091023-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091023-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091023-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091023-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091023-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091023-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091023-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091023-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091023-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091023-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091023-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091023-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091023-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091023-001	AB	1	`ea99ee380514…`

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 bisulfate	CLOPIDOGREL BISULFATE	REMEDYREPACK INC.	e5ee3807-5c9d-4b65-b188-4159a0fb1c85	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091023 application number: ANDA091023
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Quallent Pharmaceuticals Health LLC	d072b6ea-2bb4-8965-918e-23f9080efcb0	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091023 application number: ANDA091023
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	McKesson Corporation dba SKY Packaging	823c5dd0-f4e6-9b45-54de-a609caa8fa90	2025-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091023 application number: ANDA091023 ndc (product): 63739-178
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Dr.Reddy's Laboratories Inc	45caaa95-8470-b459-5f82-8156072d1878	2025-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091023 application number: ANDA091023
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Dr.Reddy's Laboratories Limited	4da4da53-91ae-4d4f-145f-255c5db443a5	2023-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091023 application number: ANDA091023 ndc (product): 55111-671

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-671	Clopidogrel bisulfate	Clopidogrel bisulfate	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-671	Clopidogrel bisulfate	Clopidogrel bisulfate	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-671	Clopidogrel bisulfate	Clopidogrel bisulfate	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-671	Clopidogrel bisulfate	Clopidogrel bisulfate	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-671	Clopidogrel bisulfate	Clopidogrel bisulfate	Dr.Reddy's Laboratories Limited	ANDA	Current
63739-178	Clopidogrel bisulfate	Clopidogrel bisulfate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-178	Clopidogrel bisulfate	Clopidogrel bisulfate	McKesson Corporation dba SKY Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31511	ORIG	2012-05-18