Application 213351

Type: ANDA
Sponsor: POLYGEN PHARMS

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
002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	TABLET;ORAL	EQ 300MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213351-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB		2020-07-17
A213351-002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB		2020-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213351-001	AB
A213351-002	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 · 78 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
2026-09-14 22:38:34	2026-08	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213351-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2020-07-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213351-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL	AB	2020-07-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213351-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213351-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213351-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213351-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213351-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213351-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213351-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213351-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213351-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213351-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213351-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213351-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213351-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213351-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213351-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213351-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213351-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213351-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213351-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213351-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213351-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213351-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213351-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213351-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213351-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213351-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213351-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213351-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213351-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213351-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213351-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213351-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213351-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213351-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213351-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213351-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213351-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213351-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213351-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213351-002	AB	1	`bb7c543d1eb4…`

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 2 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	Dr.Reddy's Laboratories Inc	45caaa95-8470-b459-5f82-8156072d1878	2025-03-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel Bisulfate	CLOPIDOGREL BISULFATE	PD-Rx Pharmaceuticals, Inc.	03bec9ad-cd22-44d3-9b82-2796157de1d1	2025-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel Bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	PD-Rx Pharmaceuticals, Inc.	20247bf8-30ec-4807-95c1-8ec7587368ae	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
CLOPIDOGREL	CLOPIDOGREL BISULFATE	A-S Medication Solutions	ffeb2fca-d475-4d93-913d-0048ff9fcee9	2024-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
CLOPIDOGREL	CLOPIDOGREL BISULFATE	A-S Medication Solutions	2564e8ee-fa2d-49d1-9a1a-6f3eb1e74032	2024-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	A-S Medication Solutions	e19174f4-ec3c-4cd6-ad7d-d1e882f9d7b4	2024-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	NuCare Pharmaceuticals,Inc.	a7bf847d-43e9-166e-e053-2995a90a239e	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	Bryant Ranch Prepack	e8f98886-4771-4be3-8b57-edfbbc1b4661	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	Aurobindo Pharma Limited	0078fb3d-3595-4ae1-a059-1d5e81c879cf	2024-05-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	Proficient Rx LP	330702d9-842c-416d-9b11-b4a9b707e9b2	2024-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Bryant Ranch Prepack	539265a6-e356-42cd-bde9-ac704f108c74	2024-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Dr.Reddy's Laboratories Limited	4da4da53-91ae-4d4f-145f-255c5db443a5	2023-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	RADHA PHARMACEUTICALS, INC.	16aef4f6-6b90-4d5f-9e07-c9927adf3841	2023-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Bryant Ranch Prepack	7c4b3bc3-8f3b-4232-835d-e37d93b92c3e	2023-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	ScieGen Pharmaceuticals Inc	d03cfc18-c9e4-41f8-b54d-6a7564c32afb	2023-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	A-S Medication Solutions	b6e6a9b8-bf91-4e7f-b872-880afb558426	2023-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	Westminster Pharmaceuticals, LLC	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	2023-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel Bisulfate	CLOPIDOGREL BISULFATE	Sun Pharmaceutical Industries, Inc.	d37db064-3a5a-4a0c-a60b-b4b417fe742a	2022-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel Bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	Proficient Rx LP	ec296eed-81d0-4c1e-bff4-431851899157	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	Aphena Pharma Solutions - Tennessee, LLC	d49362ae-f78a-47d8-ac14-8262d621fcaa	2021-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback 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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52605-082	clopidogrel	clopidogrel	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-082	clopidogrel	clopidogrel	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-082	clopidogrel	clopidogrel	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-083	Clopidogrel	Clopidogrel	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-083	Clopidogrel	Clopidogrel	POLYGEN PHARMACEUTICALS INC.	ANDA	Current
52605-083	Clopidogrel	Clopidogrel	POLYGEN PHARMACEUTICALS INC.	ANDA	Current