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 44.

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N209139-001	PREXXARTAN	VALSARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209139-001	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 · 81 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
2026-10-15 13:18:30	2026-09	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19	`caaa826d4ba7…`
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UTC	2026-02	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`011fe1cb6892…`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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N209139-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209139-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209139-001	AB	1	`caaa826d4ba7…`

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 2 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	A-S Medication Solutions	d9af6ba1-c760-4af6-b733-88e4892d4cb6	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	AvKARE	a8c61488-4219-dfcb-e053-2a95a90a98a4	2026-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	f2b77f2f-333e-f3e3-e053-2a95a90a1fa7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	f305e9d7-341a-45f6-e053-2a95a90a2d69	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	f756009f-f04f-6518-e053-6294a90a79ed	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	03af7d09-314a-fe85-e063-6294a90afa25	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
valsartan	VALSARTAN	Northwind Health Company, LLC	db4801e5-6e0f-2cb3-e053-2995a90a709a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Ascend Laboratories, LLC	7b4ecaf9-e84c-4660-9cd1-65a238efd8a8	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Coupler LLC	3eee9505-ebba-76e3-e063-6294a90acd6e	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Coupler LLC	3dfe5407-96a6-d2f4-e063-6294a90aa810	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Solco Healthcare US, LLC	26080940-bcd3-446d-9026-3ddfb58e281e	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Dr. Reddy's Laboratories Limited	75235313-8a07-8849-9b5a-12887992033e	2025-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
valsartan	VALSARTAN	PD-Rx Pharmaceuticals, Inc.	5afd7c3d-c66b-479c-bfd0-6c04658b157d	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Proficient Rx LP	f59f71d3-c143-43e5-ac22-0b1d741f4a81	2025-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
VALSARTAN	VALSARTAN	Direct_Rx	946692f5-0fe2-89b7-e053-2995a90a4d91	2025-01-27	Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Camber Pharmaceuticals, Inc.	0ff36e83-b307-42db-a2ab-bae3f6805c20	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	AvPAK	0878f27e-5368-c93f-e063-6394a90a1086	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	2847db2a-fcc9-4776-875a-ba6d57d5ea8b	2024-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	American Health Packaging	7ea2fdf1-4fda-47a7-8110-62fb6468c989	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Viona Pharmaceuticals Inc	bd7b35c7-9f01-4afd-b497-bbe0f3d69b29	2024-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN

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 · 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