Application 201686

Type: ANDA
Sponsor: CADILA

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 43.

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
A201686-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL			2012-10-10

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201686-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	2012-10-10	`f41ea6bd6efb…`

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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Proficient Rx LP	4842be24-3919-48ae-9302-eb9d3d921224	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1417	clopidogrel	clopidogrel	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1417	clopidogrel	clopidogrel	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1062	clopidogrel	clopidogrel	Cadila Healthcare Limited	ANDA	Current
70771-1062	clopidogrel	clopidogrel	Zydus Lifesciences Limited	ANDA	Current
70771-1062	clopidogrel	clopidogrel	Cadila Healthcare Limited	ANDA	Current
70771-1062	clopidogrel	clopidogrel	Cadila Healthcare Limited	ANDA	Current
72578-012	clopidogrel	clopidogrel	Viona Pharmaceuticals Inc	ANDA	Current
72578-012	clopidogrel	clopidogrel	Viona Pharmaceuticals Inc	ANDA	Current