Home Applications 205345 Application 205345
Type ANDA
Sponsor HETERO LABS LTD V 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 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 A205345-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 A205345-002 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04
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 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 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205345-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2023-08-04 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205345-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2023-08-04 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLOPIDOGREL CLOPIDOGREL Camber Pharmaceuticals, Inc. b573aefa-e337-478f-97e4-eb8472a7e497 2023-09-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205345 application number: ANDA205345