Home Applications 077665 Application 077665
Type ANDA
Sponsor MYLAN PHARMS INC 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 A077665-001 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 A077665-002 CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG 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 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 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077665-001 CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET / ORAL 2012-05-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077665-002 CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET / ORAL 2012-05-17 74a2ff9319b5…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-09-15 20:21 UTC 2019-09 A077665-001 AB 1 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077665-001 AB 1 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 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-3627 Clopidogrel Bisulfate clopidogrel Mylan Pharmaceuticals Inc. ANDA Current 0378-3627 Clopidogrel Bisulfate clopidogrel Mylan Pharmaceuticals Inc. ANDA Current 51079-558 Clopidogrel Bisulfate clopidogrel Mylan Institutional Inc. ANDA Current 55154-5388 Clopidogrel Bisulfate clopidogrel Cardinal Health ANDA Current 55154-5388 Clopidogrel Bisulfate clopidogrel Cardinal Health ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9074 ORIG 2012-05-18