Application 019309

Type: NDA
Sponsor: BIOVAIL LABS INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VASOTEC	ENALAPRILAT	INJECTABLE;INJECTION	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N019309-001	VASOTEC	ENALAPRILAT	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1988-02-09

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 · 41 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UTC	2026-02	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019309-001	VASOTEC	1.25MG/ML	INJECTABLE / INJECTION	RLD	1988-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019309-001	VASOTEC	1.25MG/ML	INJECTABLE / INJECTION	RLD	1988-02-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019309-001	VASOTEC	1.25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1988-02-09	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vasotec	ENALAPRIL MALEATE	Bausch Health US LLC	39631f1f-5d19-43c1-b504-bf56d991ed97	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vasotec
Enalaprilat	ENALAPRILAT	Dr. Reddys Laboratories Inc	5d398da1-020c-ccb1-a775-ce8e0b29d621	2024-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRILAT
ENALAPRILAT	ENALAPRILAT	HF Acquisition Co LLC, DBA HealthFirst	9d88f915-13dd-5463-e053-2a95a90a09bf	2024-02-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRILAT
Enalaprilat	ENALAPRILAT	Hikma Pharmaceuticals USA Inc.	eabae489-e254-4987-ab90-7cda20a6f856	2024-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRILAT

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40889	SUPPL	2011-02-15
20217	SUPPL	2011-02-15
40892	SUPPL	2007-07-24
40890	SUPPL	2007-07-24
20218	SUPPL	2007-07-24
40893	SUPPL	2007-07-09
20222	SUPPL	2007-07-09
20219	SUPPL	2007-07-09
40891	SUPPL	2006-10-26
20221	SUPPL	2006-10-26
20220	SUPPL	2006-10-26
44031	ORIG	2006-06-09
11474	SUPPL	2004-06-29
1282	SUPPL	2004-06-29
17357	SUPPL	2002-10-30
40895	SUPPL	2001-11-27
20223	SUPPL	2001-06-22
40894	SUPPL	1997-06-11