Home Applications 202925 Application 202925
Type ANDA
Sponsor ACCORD HLTHCARE 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 A202925-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 A202925-002 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2013-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2013-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202925-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2013-03-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202925-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2013-03-27 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
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.
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 · 36 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16729-218 Clopidogrel Clopidogrel bisulphate Accord Healthcare Inc. ANDA Current 16729-218 Clopidogrel Clopidogrel bisulphate Accord Healthcare Inc. ANDA Current 16729-218 Clopidogrel Clopidogrel Accord Healthcare Inc. ANDA Current 16729-218 Clopidogrel Clopidogrel Accord Healthcare Inc. ANDA Current 16729-218 Clopidogrel Clopidogrel Accord Healthcare Inc. ANDA Current 16729-219 Clopidogrel Clopidogrel bisulphate Accord Healthcare Inc. ANDA Current 16729-219 Clopidogrel Clopidogrel bisulphate Accord Healthcare Inc. ANDA Current 16729-219 Clopidogrel Clopidogrel Accord Healthcare Inc. ANDA Current 16729-219 Clopidogrel Clopidogrel Accord Healthcare Inc. ANDA Current 16729-219 Clopidogrel Clopidogrel Accord Healthcare Inc. ANDA Current 50090-2598 Clopidogrel Clopidogrel bisulphate A-S Medication Solutions ANDA Current 50090-2598 Clopidogrel Clopidogrel bisulphate A-S Medication Solutions ANDA Current 50090-4918 Clopidogrel Clopidogrel A-S Medication Solutions ANDA Current 53808-1031 Clopidogrel Clopidogrel bisulphate State of Florida DOH Central Pharmacy ANDA Current 67046-100 Clopidogrel Clopidogrel bisulphate Contract Pharmacy Services-PA ANDA Current 68071-2813 Clopidogrel Clopidogrel NuCare Pharmaceuticals,Inc. ANDA Current 68071-4898 Clopidogrel Clopidogrel bisulphate NuCare Pharmaceuticals,Inc. ANDA Current 68071-4898 Clopidogrel Clopidogrel bisulphate NuCare Pharmaceuticals,Inc. ANDA Current 68788-7463 Clopidogrel Clopidogrel Preferred Pharmaceuticals, Inc. ANDA Current 68788-8190 Clopidogrel Clopidogrel Preferred Pharmaceuticals Inc. ANDA Current 70518-0471 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-0471 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-0471 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-0471 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-0471 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-0471 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-0471 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-0471 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-0471 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-0750 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-0750 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-1510 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70518-1510 Clopidogrel Clopidogrel bisulphate REMEDYREPACK INC. ANDA Current 70934-708 Clopidogrel Clopidogrel Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 71335-1409 Clopidogrel Clopidogrel Bryant Ranch Prepack ANDA Current 71335-1409 Clopidogrel Clopidogrel Bryant Ranch Prepack ANDA Current