FDA.reportPublic FDA data

Application 201686

Type
ANDA
Sponsor
CADILA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATETABLET;ORALEQ 75MG BASENoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201686-001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-10-10

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A201686-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-10-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201686-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-10-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201686-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORAL2012-10-10a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClopidogrelCLOPIDOGREL BISULFATEWestminster Pharmaceuticals, LLCbb3b5e96-e629-4db5-8ad5-40c17c6dae182026-09-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
CLOPIDOGRELCLOPIDOGREL BISULFATEREMEDYREPACK INC.669f0bc6-f173-484d-8efe-c006683b25d12026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfateCLOPIDOGREL BISULFATEREMEDYREPACK INC.2969deac-274b-4042-9c90-9522e62a979d2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clopidogrel bisulfate
generic name: CLOPIDOGREL BISULFATE
CLOPIDOGRELCLOPIDOGREL BISULFATEPreferred Pharmaceuticals Inc.c9928956-bb7b-4ec2-bc38-d3c9c4199cae2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
ClopidogrelCLOPIDOGREL BISULFATEREMEDYREPACK INC.3e2539c1-a6ad-4d60-944c-c2e7aa70ce452026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfateCLOPIDOGREL BISULFATEREMEDYREPACK INC.e5ee3807-5c9d-4b65-b188-4159a0fb1c852026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clopidogrel bisulfate
generic name: CLOPIDOGREL BISULFATE
CLOPIDOGRELCLOPIDOGREL BISULFATEAscend Laboratories, LLCdb1161c9-6efd-4361-a766-6a37c241ccee2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
ClopidogrelCLOPIDOGREL BISULFATECardinal Health 107, LLCc03a895c-2d74-4d7f-891f-b752ce409b682026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfateCLOPIDOGREL BISULFATEPreferred Pharmaceuticals, Inc.e51d4bcc-01df-409d-9179-45e6536ac25b2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clopidogrel bisulfate
generic name: CLOPIDOGREL BISULFATE
ClopidogrelCLOPIDOGREL BISULFATELegacy Pharmaceutical Packaging, LLC53de10a5-dbd0-413d-90e5-00a1920ec3912026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
ClopidogrelCLOPIDOGREL BISULFATENuCare Pharmaceuticals,Inc.553b4938-4462-4aeb-e054-00144ff88e882026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
ClopidogrelCLOPIDOGREL BISULFATENuCare Pharmaceuticals,Inc.55530ff3-5ce4-120f-e054-00144ff8d46c2026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfateCLOPIDOGREL BISULFATENCS HealthCare of KY, LLC dba Vangard Labs8406b8e3-e203-402f-8858-2748119e23512026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clopidogrel bisulfate
generic name: CLOPIDOGREL BISULFATE
ClopidogrelCLOPIDOGREL BISULFATEAvPAK94a5cdc4-e063-1d46-e053-2995a90a7e152026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
CLOPIDOGRELCLOPIDOGREL BISULFATENovadoz Pharmaceuticals LLC1447a095-c663-4f05-91d4-f09bfc0c3d422025-11-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfateCLOPIDOGREL BISULFATEQuallent Pharmaceuticals Health LLCd072b6ea-2bb4-8965-918e-23f9080efcb02025-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clopidogrel bisulfate
generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfateCLOPIDOGREL BISULFATEQuallent Pharmaceuticals Health LLC333c7992-d481-b7d4-404f-9a49c85b63312025-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clopidogrel bisulfate
generic name: CLOPIDOGREL BISULFATE
ClopidogrelCLOPIDOGREL BISULFATEApotex Corp.edae8df1-caf9-ff72-1304-5ae8b355f8e72025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
ClopidogrelCLOPIDOGREL BISULFATEMajor Pharmaceuticals4cd07a3c-9673-4aa0-b76a-d79df2399ee12025-09-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOPIDOGREL BISULFATE
Clopidogrel bisulfateCLOPIDOGREL BISULFATEDr.Reddy's Laboratories Limitedb5aa951f-72de-bea1-98a2-a4085c64a3612025-08-28Boxed warning, Warnings, Adverse reactionsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1417clopidogrelclopidogrelZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1417clopidogrelclopidogrelZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1062clopidogrelclopidogrelCadila Healthcare LimitedANDACurrent
70771-1062clopidogrelclopidogrelZydus Lifesciences LimitedANDACurrent
70771-1062clopidogrelclopidogrelCadila Healthcare LimitedANDACurrent
70771-1062clopidogrelclopidogrelCadila Healthcare LimitedANDACurrent
72578-012clopidogrelclopidogrelViona Pharmaceuticals IncANDACurrent
72578-012clopidogrelclopidogrelViona Pharmaceuticals IncANDACurrent