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N209139-001	PREXXARTAN	VALSARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19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N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19	`c2088c7a36db…`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N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19	`84e616aacf4f…`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N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	AB	RLD	2017-12-19	`caaa826d4ba7…`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UTC	2026-02	N209139-001	PREXXARTAN	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-12-19	`011fe1cb6892…`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 1 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	5a816ea6-2645-bd6e-e063-6294a90a908b	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
valsartan	VALSARTAN	Jubilant Cadista Pharmaceuticals Inc.	9402b022-5809-4251-dfef-54f6ef5723fe	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	59d3db05-2d63-9dbf-e063-6394a90a8dd3	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Diovan	VALSARTAN	Novartis Pharmaceuticals Corporation	5ddba454-f3e6-43c2-a7a6-58365d297213	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
VALSARTAN	VALSARTAN	Ohm Laboratories Inc.	ab5e0e5a-5bdf-4cfc-9d18-57ea4d642f65	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Macleods Pharmaceuticals Limited	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	7aaa0a16-d7c6-4952-aa27-0b4b8982dc5f	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	ScieGen Pharmaceuticals, INC.	1a8af3d9-4053-4233-82a7-e8c7bc9e302f	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	bb3c66a7-d397-4df5-822f-4a1f797f54fc	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	04b3301f-e054-ed5d-e063-6294a90a819c	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Northwind Health Company, LLC	04b3c573-4ef7-5cf6-e063-6294a90a2c5f	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	6e9c4c57-e2c9-461b-9c09-669d3ada4c1a	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	7cb9f284-8175-4679-b846-145dc604e2c0	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	c12db287-786c-47ae-a1f3-df04ddfd2a70	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	b3880f58-ce15-4701-84aa-8eb185cf43e2	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Bryant Ranch Prepack	7b523502-62b3-425e-960b-f0a58919d3ec	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Laurus Labs Limited	6e1f63ad-e554-421b-a699-4e8c9bd4d239	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	A-S Medication Solutions	0925a24f-6a72-4c77-b4e6-0a8f5b12c8d0	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	PD-Rx Pharmaceuticals, Inc.	4d6e85d8-7d51-4447-b43d-c2a77f4fe3ae	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VALSARTAN
Valsartan	VALSARTAN	Camber Pharmaceuticals, Inc.	d6e84105-9394-4ef0-928c-20d07d3fbaa9	2026-02-17	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