Application 204165

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATETABLET;ORALEQ 75MG BASENoNo
002CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATETABLET;ORALEQ 300MG BASENoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204165-001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15
A204165-002CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204165-001AB
A204165-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204165-001CLOPIDOGREL BISULFATEEQ 75MG BASETABLET / ORALAB2014-09-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204165-002CLOPIDOGREL BISULFATEEQ 300MG BASETABLET / ORALAB2014-09-15bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204165-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204165-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204165-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204165-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204165-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204165-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204165-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204165-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204165-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204165-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204165-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204165-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204165-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204165-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204165-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204165-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204165-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204165-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204165-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204165-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204165-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204165-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204165-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204165-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204165-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204165-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204165-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204165-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204165-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204165-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204165-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204165-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204165-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204165-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204165-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204165-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204165-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204165-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204165-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204165-002AB1bb7c543d1eb4…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clopidogrel bisulfateCLOPIDOGREL BISULFATEPreferred Pharmaceuticals, Inc.e51d4bcc-01df-409d-9179-45e6536ac25b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ndc (product): 68788-7700
Clopidogrel bisulfateCLOPIDOGREL BISULFATENCS HealthCare of KY, LLC dba Vangard Labs8406b8e3-e203-402f-8858-2748119e23512026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ClopidogrelCLOPIDOGREL BISULFATEAvPAK94a5cdc4-e063-1d46-e053-2995a90a7e152026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ndc (product): 50268-184
Clopidogrel bisulfateCLOPIDOGREL BISULFATEREMEDYREPACK INC.2969deac-274b-4042-9c90-9522e62a979d2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATENuCare Pharmaceuticals,Inc.a7bf847d-43e9-166e-e053-2995a90a239e2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ndc (product): 68071-5277
ClopidogrelCLOPIDOGREL BISULFATEProficient Rx LP330702d9-842c-416d-9b11-b4a9b707e9b22024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATEBryant Ranch Prepack539265a6-e356-42cd-bde9-ac704f108c742024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATERADHA PHARMACEUTICALS, INC.16aef4f6-6b90-4d5f-9e07-c9927adf38412023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
Clopidogrel bisulfateCLOPIDOGREL BISULFATEBryant Ranch Prepack7c4b3bc3-8f3b-4232-835d-e37d93b92c3e2023-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ndc (product): 71335-1646
Clopidogrel bisulfateCLOPIDOGREL BISULFATEScieGen Pharmaceuticals Incd03cfc18-c9e4-41f8-b54d-6a7564c32afb2023-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ndc (product): 50228-121
ndc (product): 50228-124
ClopidogrelCLOPIDOGREL BISULFATEWestminster Pharmaceuticals, LLCbb3b5e96-e629-4db5-8ad5-40c17c6dae182023-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ndc (product): 69367-194
Clopidogrel bisulfateCLOPIDOGREL BISULFATEProficient Rx LP4842be24-3919-48ae-9302-eb9d3d9212242019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ndc (product): 63187-639
ClopidogrelCLOPIDOGRELVensun Pharmaceuticals, Inc.86ee71f2-850e-4c8e-87f3-c7a618d59d952019-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204165
application number: ANDA204165
ndc (product): 42543-714
ndc (product): 42543-713

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-901clopidogrelclopidogrelCamber Pharmaceuticals, Inc.ANDACurrent
31722-902clopidogrelclopidogrelCamber Pharmaceuticals, Inc.ANDACurrent
42543-713ClopidogrelclopidogrelVensun Pharmaceuticals, Inc.ANDACurrent
42543-714ClopidogrelclopidogrelVensun Pharmaceuticals, Inc.ANDACurrent
50228-121Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-121Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-121Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-121Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-121Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-121Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-121Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-124Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-124Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-124Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-124Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-124Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-124Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50228-124Clopidogrel bisulfateClopidogrel bisulfateScieGen Pharmaceuticals IncANDACurrent
50268-184ClopidogrelClopidogrel BisulfateAvPAKANDACurrent
50268-184ClopidogrelClopidogrel BisulfateAvPAKANDACurrent
62034-017Clopidogrel bisulfateClopidogrel bisulfateBlenheim Pharmacal, Inc.ANDACurrent
63187-639Clopidogrel bisulfateClopidogrel bisulfateProficient Rx LPANDACurrent
63187-639Clopidogrel bisulfateClopidogrel bisulfateProficient Rx LPANDACurrent
63629-8045Clopidogrel bisulfateClopidogrel bisulfateBryant Ranch PrepackANDACurrent
63629-8045Clopidogrel bisulfateClopidogrel bisulfateBryant Ranch PrepackANDACurrent
68071-4057Clopidogrel bisulfateClopidogrel bisulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5277Clopidogrel bisulfateClopidogrel bisulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5277Clopidogrel bisulfateClopidogrel bisulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7700Clopidogrel bisulfateClopidogrel bisulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7700Clopidogrel bisulfateClopidogrel bisulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7700Clopidogrel bisulfateClopidogrel bisulfatePreferred Pharmaceuticals, Inc.ANDACurrent
69117-1010Clopidogrel bisulfateClopidogrel bisulfateYILING PHARMACEUTICAL,INC.ANDACurrent
69117-1010Clopidogrel bisulfateClopidogrel bisulfateYILING PHARMACEUTICAL,INC.ANDACurrent
69367-194ClopidogrelClopidogrel BisulfateWestminster Pharmaceuticals, LLCANDACurrent
69367-194ClopidogrelClopidogrel BisulfateWestminster Pharmaceuticals, LLCANDACurrent
69367-194ClopidogrelClopidogrel BisulfateWestminster Pharmaceuticals, LLCANDACurrent
69367-194ClopidogrelClopidogrel BisulfateWestminster Pharmaceuticals, LLCANDACurrent
70400-101Clopidogrel bisulfateClopidogrel bisulfateSterisyn Inc.ANDACurrent
70518-0991clopidogrelclopidogrelREMEDYREPACK INC.ANDACurrent
70518-0991clopidogrelclopidogrelREMEDYREPACK INC.ANDACurrent
70518-2136Clopidogrel bisulfateClopidogrel bisulfateREMEDYREPACK INC.ANDACurrent
70934-797Clopidogrel bisulfateClopidogrel bisulfateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-797Clopidogrel bisulfateClopidogrel bisulfateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-797Clopidogrel bisulfateClopidogrel bisulfateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1232Clopidogrel bisulfateClopidogrel bisulfateBryant Ranch PrepackANDACurrent
71335-1232Clopidogrel bisulfateClopidogrel bisulfateBryant Ranch PrepackANDACurrent
71335-1646Clopidogrel bisulfateClopidogrel bisulfateBryant Ranch PrepackANDACurrent
71335-1646Clopidogrel bisulfateClopidogrel bisulfateBryant Ranch PrepackANDACurrent
71399-7500Clopidogrel bisulfateClopidogrel bisulfateAkron Pharma IncANDACurrent