Application 205897

Type: ANDA
Sponsor: PANACEA BIOTEC LTD

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 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
A205897-001	PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2017-10-16
A205897-002	PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2017-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205897-001	AB
A205897-002	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205897-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205897-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205897-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205897-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205897-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205897-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205897-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205897-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205897-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205897-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205897-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205897-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205897-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205897-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205897-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205897-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205897-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205897-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205897-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205897-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205897-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205897-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205897-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205897-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205897-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205897-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205897-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205897-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205897-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205897-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205897-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205897-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205897-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205897-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205897-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205897-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205897-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205897-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205897-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205897-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205897-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205897-002	AB	1	`bb7c543d1eb4…`

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 · 2 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	Exact identifier application applno (ANDA): 205897 application number: ANDA205897 ndc (product): 60505-4643 ndc (product): 60505-4642
PRASUGREL	PRASUGREL	Panacea Biotec Limited	944c195a-de24-a44c-8baa-84b624b5ddcb	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205897 application number: ANDA205897 ndc (product): 43817-239 ndc (product): 43817-240

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43817-239	Prasugrel	Prasugrel	Panacea Biotec Limited	ANDA	Current
43817-239	Prasugrel	Prasugrel	Panacea Biotec Ltd.	ANDA	Current
43817-240	Prasugrel	Prasugrel	Panacea Biotec Limited	ANDA	Current
43817-240	Prasugrel	Prasugrel	Panacea Biotec Ltd.	ANDA	Current
51407-247	Prasugrel	Prasugrel	Golden State Medical Supply	ANDA	Current
51407-247	Prasugrel	Prasugrel	Golden State Medical Supply, Inc.	ANDA	Current
51407-247	Prasugrel	Prasugrel	Golden State Medical Supply, Inc.	ANDA	Current
51407-248	Prasugrel	Prasugrel	Golden State Medical Supply	ANDA	Current
51407-248	Prasugrel	Prasugrel	Golden State Medical Supply, Inc.	ANDA	Current
51407-248	Prasugrel	Prasugrel	Golden State Medical Supply, Inc.	ANDA	Current
60505-4642	Prasugrel	Prasugrel	Apotex Corp.	ANDA	Current
60505-4642	Prasugrel	Prasugrel	Apotex Corp.	ANDA	Current
60505-4643	Prasugrel	Prasugrel	Apotex Corp.	ANDA	Current
60505-4643	Prasugrel	Prasugrel	Apotex Corp.	ANDA	Current
60687-412	Prasugrel	Prasugrel	American Health Packaging	ANDA	Current
60687-412	Prasugrel	Prasugrel	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50122	ORIG	2017-10-19