Home Applications 213351 Application 213351
Type ANDA
Sponsor POLYGEN PHARMS 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 A213351-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 A213351-002 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17
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 · 76 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 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213351-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL AB 2020-07-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213351-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL AB 2020-07-17 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 52605-082 clopidogrel clopidogrel POLYGEN PHARMACEUTICALS INC. ANDA Current 52605-082 clopidogrel clopidogrel POLYGEN PHARMACEUTICALS INC. ANDA Current 52605-082 clopidogrel clopidogrel POLYGEN PHARMACEUTICALS INC. ANDA Current 52605-083 Clopidogrel Clopidogrel POLYGEN PHARMACEUTICALS INC. ANDA Current 52605-083 Clopidogrel Clopidogrel POLYGEN PHARMACEUTICALS INC. ANDA Current 52605-083 Clopidogrel Clopidogrel POLYGEN PHARMACEUTICALS INC. ANDA Current