Application 209139

Type: NDA
Sponsor: CARMEL BIOSCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREXXARTAN	VALSARTAN	SOLUTION;ORAL	20MG/5ML	Yes	No
002	PREXXARTAN	VALSARTAN	SOLUTION;ORAL	80MG/20ML	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209139-001	PREXXARTAN	VALSARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209139-001	PREXXARTAN	20MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209139-002	PREXXARTAN	80MG/20ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL	RLD	2017-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL	RLD	2017-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL	RLD	2017-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL	RLD	2017-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL	RLD	2017-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL	RLD	2017-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL	RLD	2017-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL	RLD	2017-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL	RLD	2017-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL	RLD	2017-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL	RLD	2017-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL	RLD	2017-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL	RLD	2017-12-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209139-002	PREXXARTAN	80MG/20ML	SOLUTION / ORAL	RLD	2017-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209139-001	PREXXARTAN	20MG/5ML	SOLUTION / ORAL	RLD	2017-12-19	`5aa47cf7b7d7…`

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
PREXXARTAN	PREXXARTAN	AptaPharma Inc.	508c5de8-9c70-57f5-e063-6394a90af295	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209139 application number: NDA209139

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25208-100	PREXXARTAN	PREXXARTAN	Medicure International Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54736	ORIG	2018-07-02
50902	ORIG	2017-12-27
50759	ORIG	2017-12-19