Home Applications 022307 Application 022307
Type NDA
Sponsor ELI LILLY AND CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EFFIENT PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Yes No 002 EFFIENT PRASUGREL HYDROCHLORIDE TABLET;ORAL EQ 10MG 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 N022307-001 EFFIENT PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 N022307-002 EFFIENT PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10
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 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022307-001 EFFIENT EQ 5MG BASE TABLET / ORAL AB RLD 2009-07-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022307-002 EFFIENT EQ 10MG BASE TABLET / ORAL AB RLD, RS 2009-07-10 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book exclusivity 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Effient PRASUGREL HYDROCHLORIDE Cosette Pharmaceuticals, Inc. 69ea2d58-5353-4222-b61f-cab976fa7e5e 2022-09-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022307 application number: NDA022307 ndc (product): 0713-0881 ndc (product): 0713-0882
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-5121 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5121 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5121 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5121 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5121 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5121 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5121 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5123 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5123 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5123 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5123 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5123 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5123 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0002-5123 Effient Prasugrel hydrochloride Eli Lilly and Company NDA Current 0713-0881 Effient Prasugrel Hydrochloride Cosette Pharmaceuticals, Inc. NDA Current 0713-0881 Effient Prasugrel Hydrochloride Cosette Pharmaceuticals, Inc. NDA Current 0713-0882 Effient Prasugrel Hydrochloride Cosette Pharmaceuticals, Inc. NDA Current 0713-0882 Effient Prasugrel Hydrochloride Cosette Pharmaceuticals, Inc. NDA Current 65597-601 Effient Prasugrel Hydrochloride Daiichi Sankyo, Inc. NDA Current 65597-601 Effient Prasugrel Hydrochloride Daiichi Sankyo Inc. NDA Current 65597-601 Effient Prasugrel Hydrochloride Daiichi Sankyo, Inc. NDA Current 65597-602 Effient Prasugrel Hydrochloride Daiichi Sankyo, Inc. NDA Current 65597-602 Effient Prasugrel Hydrochloride Daiichi Sankyo Inc. NDA Current 65597-602 Effient Prasugrel Hydrochloride Daiichi Sankyo, Inc. NDA Current