Home Applications 020839 Application 020839
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PLAVIX CLOPIDOGREL BISULFATE TABLET;ORAL EQ 75MG BASE Yes No 002 PLAVIX CLOPIDOGREL BISULFATE TABLET;ORAL EQ 300MG BASE Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020839-001 PLAVIX CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 N020839-002 PLAVIX CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD, RS 2007-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020839-001 PLAVIX EQ 75MG BASE TABLET / ORAL AB RLD 1997-11-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020839-002 PLAVIX EQ 300MG BASE TABLET / ORAL AB RLD 2007-09-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020839-001 6429210 2019-06-10 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-001 6504030 2019-06-10 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-001 6429210*PED 2019-12-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-001 6504030*PED 2019-12-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-002 6429210 2019-06-10 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-002 6504030 2019-06-10 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-002 6429210*PED 2019-12-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020839-002 6504030*PED 2019-12-10 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N020839-001 6429210 2019-06-10 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-001 6504030 2019-06-10 Drug substance 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-001 6429210*PED 2019-12-10 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-001 6504030*PED 2019-12-10 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-002 6429210 2019-06-10 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-002 6504030 2019-06-10 Drug substance 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-002 6429210*PED 2019-12-10 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020839-002 6504030*PED 2019-12-10 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020839-001 6429210 2019-06-10 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-001 6504030 2019-06-10 Drug substance b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-001 6429210*PED 2019-12-10 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-001 6504030*PED 2019-12-10 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-002 6429210 2019-06-10 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-002 6504030 2019-06-10 Drug substance b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-002 6429210*PED 2019-12-10 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020839-002 6504030*PED 2019-12-10 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020839-001 6429210 2019-06-10 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-001 6504030 2019-06-10 Drug substance ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-001 6429210*PED 2019-12-10 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-001 6504030*PED 2019-12-10 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-002 6429210 2019-06-10 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-002 6504030 2019-06-10 Drug substance ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-002 6429210*PED 2019-12-10 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020839-002 6504030*PED 2019-12-10 Pediatric extension 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 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 30 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-1171 Plavix clopidogrel sanofi-aventis U.S. LLC NDA Current 0024-1171 Plavix clopidogrel sanofi-aventis U.S. LLC NDA Current 0024-1171 Plavix clopidogrel sanofi-aventis U.S. LLC NDA Current 0024-1332 Plavix clopidogrel sanofi-aventis U.S. LLC NDA Current 0024-1332 Plavix clopidogrel sanofi-aventis U.S. LLC NDA Current 0024-1332 Plavix clopidogrel sanofi-aventis U.S. LLC NDA Current 21695-665 Plavix clopidogrel bisulfate Rebel Distributors Corp NDA Current 53808-0763 Plavix clopidogrel bisulfate State of Florida DOH Central Pharmacy NDA Current 55289-911 Plavix clopidogrel bisulfate PD-Rx Pharmaceuticals, Inc. NDA Current 55289-911 Plavix clopidogrel bisulfate PD-Rx Pharmaceuticals, Inc. NDA Current 55289-911 Plavix clopidogrel bisulfate PD-Rx Pharmaceuticals, Inc. NDA Current 55289-911 Plavix clopidogrel bisulfate PD-Rx Pharmaceuticals, Inc. NDA Current 55289-911 Plavix clopidogrel bisulfate PD-Rx Pharmaceuticals, Inc. NDA Current 55289-911 Plavix clopidogrel bisulfate PD-Rx Pharmaceuticals, Inc. NDA Current 55289-911 Plavix clopidogrel bisulfate PD-Rx Pharmaceuticals, Inc. NDA Current 63653-1171 Plavix clopidogrel Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1171 Plavix clopidogrel bisulfate Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1171 Plavix clopidogrel bisulfate Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1171 Plavix clopidogrel Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1171 Plavix clopidogrel bisulfate Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1171 Plavix clopidogrel bisulfate Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1171 Plavix clopidogrel Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1332 Plavix clopidogrel Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1332 Plavix clopidogrel bisulfate Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1332 Plavix clopidogrel bisulfate Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1332 Plavix clopidogrel Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1332 Plavix clopidogrel bisulfate Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1332 Plavix clopidogrel bisulfate Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 63653-1332 Plavix clopidogrel Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership NDA Current 67046-604 Plavix clopidogrel bisulfate Contract Pharmacy Services-PA NDA Current