Application 205790

Type: ANDA
Sponsor: USPHARMA WINDLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRASUGREL	PRASUGREL HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	No	No
002	PRASUGREL	PRASUGREL HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A205790-001	PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL			2017-10-16
A205790-002	PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2017-10-16

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A205790-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205790-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205790-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205790-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205790-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205790-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205790-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205790-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205790-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205790-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205790-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205790-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205790-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205790-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205790-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205790-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205790-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205790-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205790-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205790-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205790-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205790-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205790-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205790-002	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 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRASUGREL	PRASUGREL	Apotex Corp.	f51e64e0-f556-65d0-a876-fb709aaeefea	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PRASUGREL
Prasugrel	PRASUGREL	American Health Packaging	35aa7f3e-bbd8-4eae-b61f-29d1abca2224	2025-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prasugrel
PRASUGREL	PRASUGREL	Panacea Biotec Limited	944c195a-de24-a44c-8baa-84b624b5ddcb	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PRASUGREL
Prasugrel	PRASUGREL	Bryant Ranch Prepack	9c3994da-da45-43ce-9727-a842a43c5693	2024-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prasugrel
Prasugrel	PRASUGREL	Golden State Medical Supply, Inc.	bb78f952-69a5-1620-e053-2a95a90afe97	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prasugrel
Prasugrel	PRASUGREL	Aurobindo Pharma Limited	596c923d-db8d-4b96-bf31-52186a38c30d	2024-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prasugrel
Prasugrel	PRASUGREL	Accord Healthcare Inc.	cd6bf899-06b7-4f52-96c5-ffc94a7288ff	2024-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prasugrel
Prasugrel	PRASUGREL	Unichem Pharmaceuticals (USA), Inc.	5edc1ab3-5c7a-47d6-8aaa-00523c9b4c8f	2023-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prasugrel
Effient	PRASUGREL HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	69ea2d58-5353-4222-b61f-cab976fa7e5e	2022-09-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PRASUGREL HYDROCHLORIDE
Prasugrel	PRASUGREL	Mylan Pharmaceuticals Inc.	41a4e332-6725-4cb7-940a-8291cf56cfe4	2022-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prasugrel
Prasugrel	PRASUGREL	Amneal Pharmaceuticals LLC	406cc201-89b6-43cc-9e14-a59327a5b4d8	2022-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prasugrel

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-0604	PRASUGREL	Prasugrel	Liberty Pharmaceuticals, Inc.	ANDA	Current
0440-0605	PRASUGREL	Prasugrel	Liberty Pharmaceuticals, Inc.	ANDA	Current
67877-604	PRASUGREL	Prasugrel	Ascend Laboratories, LLC	ANDA	Current
67877-604	PRASUGREL	Prasugrel	Ascend Laboratories, LLC	ANDA	Current
67877-604	PRASUGREL	Prasugrel	Ascend Laboratories, LLC	ANDA	Current
67877-605	PRASUGREL	Prasugrel	Ascend Laboratories, LLC	ANDA	Current
67877-605	PRASUGREL	Prasugrel	Ascend Laboratories, LLC	ANDA	Current
67877-605	PRASUGREL	Prasugrel	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50119	ORIG	2017-10-19