Application 018998

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VASOTEC	ENALAPRIL MALEATE	TABLET;ORAL	5MG	Yes	No
002	VASOTEC	ENALAPRIL MALEATE	TABLET;ORAL	10MG	Yes	No
003	VASOTEC	ENALAPRIL MALEATE	TABLET;ORAL	20MG	Yes	Yes
005	VASOTEC	ENALAPRIL MALEATE	TABLET;ORAL	2.5MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018998-001	VASOTEC	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	RLD	1985-12-24
N018998-002	VASOTEC	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	RLD	1985-12-24
N018998-003	VASOTEC	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24
N018998-005	VASOTEC	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N018998-001	AB
N018998-002	AB
N018998-003	AB
N018998-005	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 5 · 172 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
2026-09-14 22:38:34	2026-08	N018998-001	VASOTEC	5MG	TABLET / ORAL	AB	RLD	1985-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018998-002	VASOTEC	10MG	TABLET / ORAL	AB	RLD	1985-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018998-003	VASOTEC	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018998-005	VASOTEC	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018998-001	VASOTEC	5MG	TABLET / ORAL	AB	RLD	1985-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018998-002	VASOTEC	10MG	TABLET / ORAL	AB	RLD	1985-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018998-003	VASOTEC	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018998-005	VASOTEC	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018998-001	VASOTEC	5MG	TABLET / ORAL	AB	RLD	1985-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018998-002	VASOTEC	10MG	TABLET / ORAL	AB	RLD	1985-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018998-003	VASOTEC	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018998-005	VASOTEC	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018998-001	VASOTEC	5MG	TABLET / ORAL	AB	RLD	1985-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018998-002	VASOTEC	10MG	TABLET / ORAL	AB	RLD	1985-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018998-003	VASOTEC	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018998-005	VASOTEC	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018998-001	VASOTEC	5MG	TABLET / ORAL	AB	RLD	1985-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018998-002	VASOTEC	10MG	TABLET / ORAL	AB	RLD	1985-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018998-003	VASOTEC	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018998-005	VASOTEC	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018998-001	VASOTEC	5MG	TABLET / ORAL	AB	RLD	1985-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018998-002	VASOTEC	10MG	TABLET / ORAL	AB	RLD	1985-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018998-003	VASOTEC	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018998-005	VASOTEC	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018998-001	VASOTEC	5MG	TABLET / ORAL	AB	RLD	1985-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018998-002	VASOTEC	10MG	TABLET / ORAL	AB	RLD	1985-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018998-003	VASOTEC	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018998-005	VASOTEC	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018998-001	VASOTEC	5MG	TABLET / ORAL	AB	RLD	1985-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018998-002	VASOTEC	10MG	TABLET / ORAL	AB	RLD	1985-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018998-003	VASOTEC	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018998-005	VASOTEC	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018998-001	VASOTEC	5MG	TABLET / ORAL	AB	RLD	1985-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018998-002	VASOTEC	10MG	TABLET / ORAL	AB	RLD	1985-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018998-003	VASOTEC	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018998-005	VASOTEC	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018998-001	VASOTEC	5MG	TABLET / ORAL	AB	RLD	1985-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018998-002	VASOTEC	10MG	TABLET / ORAL	AB	RLD	1985-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018998-003	VASOTEC	20MG	TABLET / ORAL	AB	RLD, RS	1985-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018998-005	VASOTEC	2.5MG	TABLET / ORAL	AB	RLD	1988-07-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N018998-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018998-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018998-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018998-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018998-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018998-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018998-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018998-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018998-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018998-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018998-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018998-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018998-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018998-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018998-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018998-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018998-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018998-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018998-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018998-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018998-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018998-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018998-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018998-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018998-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018998-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018998-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018998-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018998-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018998-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018998-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018998-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018998-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018998-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018998-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018998-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018998-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018998-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018998-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018998-005	AB	1	`5bbf6a4d5a75…`

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 · 3 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	Exact identifier application applno (NDA): 018998 application number: NDA018998
Enalapril Maleate	ENALAPRIL MALEATE	OCEANSIDE PHARMACEUTICALS	ebd2a62d-a704-4f8a-a104-749a5296502f	2020-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018998 application number: NDA018998
Enalapril Maleate	ENALAPRIL MALEATE	Proficient Rx LP	cc921315-8da1-487c-ba19-433470f5c8d8	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018998 application number: NDA018998

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 2 of 2 · 95 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-0305	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0478	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0478	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0478	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0478	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0478	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1141	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1141	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1141	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1141	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1141	Enalapril Maleate	Enalapril Maleate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
72789-031	Enalapril Maleate	Enalapril Maleate	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-031	Enalapril Maleate	Enalapril Maleate	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-031	Enalapril Maleate	Enalapril Maleate	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-031	Enalapril Maleate	Enalapril Maleate	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55354	SUPPL	2018-08-29
49048	SUPPL	2017-07-25
1193	SUPPL	2015-08-27
33685	SUPPL	2015-08-26
33684	SUPPL	2015-01-09
1192	SUPPL	2014-12-30
16167	SUPPL	2012-09-17
11409	SUPPL	2012-09-14
1191	SUPPL	2012-02-23
33683	SUPPL	2012-02-22
40852	SUPPL	2011-02-15
20186	SUPPL	2011-02-15
40849	SUPPL	2011-01-04
20185	SUPPL	2011-01-04
20184	SUPPL	2011-01-04
11408	SUPPL	2010-05-18
1190	SUPPL	2008-09-29
20178	SUPPL	2007-11-19
20177	SUPPL	2007-11-19
20176	SUPPL	2007-11-19
1189	SUPPL	2007-11-08
40847	SUPPL	2007-09-14
20183	SUPPL	2007-09-14
20179	SUPPL	2007-09-14
40846	SUPPL	2007-07-20
40845	SUPPL	2007-07-20
20182	SUPPL	2007-07-20
40848	SUPPL	2007-07-06
40844	SUPPL	2007-07-06
20189	SUPPL	2007-07-06
20188	SUPPL	2007-07-06
20181	SUPPL	2007-07-06
20180	SUPPL	2007-07-06
40851	SUPPL	2007-06-12
40850	SUPPL	2007-06-12
20187	SUPPL	2007-06-12
40853	SUPPL	2007-04-09
20190	SUPPL	2007-04-09
40856	SUPPL	2006-10-26
40843	SUPPL	2006-10-26
40842	SUPPL	2006-10-26
40841	SUPPL	2006-10-26
20194	SUPPL	2006-10-25
20193	SUPPL	2006-10-25
44027	ORIG	2006-06-09
20175	ORIG	2005-04-27
16166	SUPPL	2002-08-30
33681	SUPPL	2001-11-27
20192	SUPPL	2001-11-27
1188	SUPPL	2001-11-27
20191	SUPPL	2001-06-22
40855	SUPPL	2001-02-13
33682	SUPPL	2001-02-13
16165	SUPPL	2001-02-13
40854	SUPPL	1997-06-11