Application 075583

Type: ANDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	TABLET;ORAL	2.5MG	No	No
002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	TABLET;ORAL	5MG	No	No
003	ENALAPRIL MALEATE	ENALAPRIL MALEATE	TABLET;ORAL	10MG	No	No
004	ENALAPRIL MALEATE	ENALAPRIL MALEATE	TABLET;ORAL	20MG	No	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	Approval date
A075583-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22
A075583-002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22
A075583-003	ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22
A075583-004	ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075583-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075583-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075583-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075583-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075583-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075583-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075583-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075583-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075583-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075583-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075583-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075583-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075583-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075583-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075583-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075583-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075583-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075583-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075583-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075583-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075583-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075583-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075583-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075583-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075583-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075583-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075583-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075583-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075583-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075583-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075583-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075583-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075583-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075583-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075583-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075583-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075583-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075583-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075583-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075583-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	2000-08-22	`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 2 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enalapril Maleate	ENALAPRIL MALEATE	Coupler LLC	508a58fa-9f66-e984-e063-6394a90a296a	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Preferred Pharmaceuticals Inc.	5596ba00-4a1c-4503-99db-3a9617ed17c0	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Preferred Pharmaceuicals Inc.	898b36d6-320f-4d6c-9734-0be8363dc3d7	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Preferred Pharmaceuticals Inc.	9e277302-6e6c-4a95-8f25-aaff64fb0b82	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	A-S Medication Solutions	9f913e79-fe6d-4ff2-9f8e-eef9df689fa8	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Enalapril maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	NuCare Pharmaceuticals, Inc.	315baaa6-512c-f27b-e063-6294a90a2c91	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	Legacy Pharmaceutical Packaging, LLC	ed7536f1-9a7d-4519-e053-2a95a90a4a65	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Enalapril maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	2a8ca159-c4c7-468a-bcc2-d1b879ea2c7e	2026-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Solco Healthcare US, LLC	0c829189-fba2-48f8-a23f-d5471a0345f6	2026-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	Major Pharmaceuticals	8fe8dc52-dee6-4d33-b798-e90128011f46	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Enalapril maleate generic name: ENALAPRIL MALEATE
Vasotec	ENALAPRIL MALEATE	Bausch Health US LLC	39631f1f-5d19-43c1-b504-bf56d991ed97	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	bc875f91-d781-43a9-8f7e-e2cfc019ad3f	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	ab2ffb6e-4628-e44c-e053-2a95a90a2336	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	f29ef93b-7380-2196-e053-2995a90a2ce3	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Enalapril maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	f2a0bd73-0389-3f88-e053-2995a90a72e8	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Enalapril maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	f2b3776b-02a1-311b-e053-2a95a90a2f9b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Enalapril maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	5c49fb37-1f09-4965-b213-5580d3a30a11	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Enalapril maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	Wilshire Pharmaceuticals, Inc.	c7934b45-eb6b-44c1-bd2c-ef0fa10850c1	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril maleate generic name: ENALAPRIL MALEATE
Epaned	ENALAPRIL MALEATE	Azurity Pharmaceuticals, Inc.	e6dbda02-779e-420c-893d-d0fea09432be	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATE	ENALAPRIL MALEATE	A-S Medication Solutions	aafdb635-fa17-4bfb-bcd3-86c7e7b147e2	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENALAPRIL MALEATE generic name: ENALAPRIL MALEATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8727	ORIG	2004-06-03
30946	ORIG	2000-08-22