Home Applications 090494 Application 090494
Type ANDA
Sponsor SUN PHARM 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090494-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG 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 1 of 2 · 42 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 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090494-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2012-05-17 e64feba35796…
Observed Orange Book normalized TE history# 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 · 23 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 47335-894 Clopidogrel Bisulfate Clopidogrel Bisulfate Sun Pharmaceutical Industries, Inc. ANDA Current 47335-894 Clopidogrel Bisulfate Clopidogrel Bisulfate Sun Pharmaceutical Industries, Inc. ANDA Current 47335-894 Clopidogrel Bisulfate Clopidogrel Bisulfate Sun Pharmaceutical Industries, Inc. ANDA Current 47335-894 Clopidogrel Bisulfate Clopidogrel Bisulfate Sun Pharmaceutical Industries, Inc. ANDA Current 50090-1300 Clopidogrel Bisulfate Clopidogrel Bisulfate A-S Medication Solutions ANDA Current 50090-1300 Clopidogrel Bisulfate Clopidogrel Bisulfate A-S Medication Solutions ANDA Current 50090-1300 Clopidogrel Bisulfate Clopidogrel Bisulfate A-S Medication Solutions ANDA Current 50090-1300 Clopidogrel Bisulfate Clopidogrel Bisulfate A-S Medication Solutions ANDA Current 53808-0806 Clopidogrel Bisulfate Clopidogrel Bisulfate State of Florida DOH Central Pharmacy ANDA Current 61919-737 Clopidogrel Clopidogrel Direct_Rx ANDA Current 68071-4268 Clopidogrel Bisulfate Clopidogrel Bisulfate NuCare Pharmaceuticals,Inc. ANDA Current 68071-4268 Clopidogrel Bisulfate Clopidogrel Bisulfate NuCare Pharmaceuticals,Inc. ANDA Current 68071-4268 Clopidogrel Bisulfate Clopidogrel Bisulfate NuCare Pharmaceuticals,Inc. ANDA Current 68788-7238 Clopidogrel Bisulfate Clopidogrel Bisulfate Preferred Pharmaceuticals Inc. ANDA Current 68788-7238 Clopidogrel Bisulfate Clopidogrel Bisulfate Preferred Pharmaceuticals Inc. ANDA Current 68788-7238 Clopidogrel Bisulfate Clopidogrel Bisulfate Preferred Pharmaceuticals Inc. ANDA Current 70518-0990 Clopidogrel Bisulfate Clopidogrel Bisulfate REMEDYREPACK INC. ANDA Current 70518-0990 Clopidogrel Bisulfate Clopidogrel Bisulfate REMEDYREPACK INC. ANDA Current 70518-1079 Clopidogrel Bisulfate Clopidogrel Bisulfate REMEDYREPACK INC. ANDA Current 70518-1079 Clopidogrel Bisulfate Clopidogrel Bisulfate REMEDYREPACK INC. ANDA Current 71335-0752 Clopidogrel Bisulfate Clopidogrel Bisulfate Bryant Ranch Prepack ANDA Current 71335-0752 Clopidogrel Bisulfate Clopidogrel Bisulfate Bryant Ranch Prepack ANDA Current 71335-0752 Clopidogrel Bisulfate Clopidogrel Bisulfate Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9269 ORIG 2012-05-18