Application 077665

Type: ANDA
Sponsor: MYLAN PHARMS 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
002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	TABLET;ORAL	EQ 300MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077665-001	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL			2012-05-17
A077665-002	CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL			2012-05-17

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL	AB	2012-05-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077665-001	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET / ORAL		2012-05-17	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077665-002	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET / ORAL		2012-05-17	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A077665-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077665-001	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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clopidogrel	CLOPIDOGREL BISULFATE	Westminster Pharmaceuticals, LLC	bb3b5e96-e629-4db5-8ad5-40c17c6dae18	2026-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
CLOPIDOGREL	CLOPIDOGREL BISULFATE	REMEDYREPACK INC.	669f0bc6-f173-484d-8efe-c006683b25d1	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	REMEDYREPACK INC.	2969deac-274b-4042-9c90-9522e62a979d	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
CLOPIDOGREL	CLOPIDOGREL BISULFATE	Preferred Pharmaceuticals Inc.	c9928956-bb7b-4ec2-bc38-d3c9c4199cae	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	REMEDYREPACK INC.	3e2539c1-a6ad-4d60-944c-c2e7aa70ce45	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	REMEDYREPACK INC.	e5ee3807-5c9d-4b65-b188-4159a0fb1c85	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
CLOPIDOGREL	CLOPIDOGREL BISULFATE	Ascend Laboratories, LLC	db1161c9-6efd-4361-a766-6a37c241ccee	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	Cardinal Health 107, LLC	c03a895c-2d74-4d7f-891f-b752ce409b68	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Preferred Pharmaceuticals, Inc.	e51d4bcc-01df-409d-9179-45e6536ac25b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	Legacy Pharmaceutical Packaging, LLC	53de10a5-dbd0-413d-90e5-00a1920ec391	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	NuCare Pharmaceuticals,Inc.	553b4938-4462-4aeb-e054-00144ff88e88	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	NuCare Pharmaceuticals,Inc.	55530ff3-5ce4-120f-e054-00144ff8d46c	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	NCS HealthCare of KY, LLC dba Vangard Labs	8406b8e3-e203-402f-8858-2748119e2351	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	AvPAK	94a5cdc4-e063-1d46-e053-2995a90a7e15	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
CLOPIDOGREL	CLOPIDOGREL BISULFATE	Novadoz Pharmaceuticals LLC	1447a095-c663-4f05-91d4-f09bfc0c3d42	2025-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Quallent Pharmaceuticals Health LLC	d072b6ea-2bb4-8965-918e-23f9080efcb0	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Quallent Pharmaceuticals Health LLC	333c7992-d481-b7d4-404f-9a49c85b6331	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clopidogrel bisulfate generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	Apotex Corp.	edae8df1-caf9-ff72-1304-5ae8b355f8e7	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel	CLOPIDOGREL BISULFATE	Major Pharmaceuticals	4cd07a3c-9673-4aa0-b76a-d79df2399ee1	2025-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfate	CLOPIDOGREL BISULFATE	Dr.Reddy's Laboratories Limited	b5aa951f-72de-bea1-98a2-a4085c64a361	2025-08-28	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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3627	Clopidogrel Bisulfate	clopidogrel	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3627	Clopidogrel Bisulfate	clopidogrel	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-558	Clopidogrel Bisulfate	clopidogrel	Mylan Institutional Inc.	ANDA	Current
55154-5388	Clopidogrel Bisulfate	clopidogrel	Cardinal Health	ANDA	Current
55154-5388	Clopidogrel Bisulfate	clopidogrel	Cardinal Health	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9074	ORIG	2012-05-18