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 1 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enalapril Maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	3fbc6cce-7ad5-49d5-9705-5f66ef92d544	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	5118eb9f-1466-4318-b17e-cf5898edbeef	2026-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	a5c6e64c-a3ed-44f2-83e7-f4b62b6cd622	2026-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	7077d32e-4b06-4d48-ba0c-6db2f8ebe08c	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: Enalapril maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Coupler LLC	59f44ba0-a323-493f-e063-6394a90a1c3c	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	e47afc0d-afc4-4972-a28a-5d3c640390ab	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	b4b7b936-4a62-4991-8d3c-03bb37f044c1	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	bdb34c96-1532-4ce5-93a7-3cc90904c910	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	1b464099-491d-473b-836e-9d86b2b1eeec	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	fb3c7066-76cb-4e8e-b98b-bcb41a3631df	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Golden State Medical Supply, Inc.	0a12343f-5733-40cc-93b4-a02f5147fb91	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Bryant Ranch Prepack	fa93d8e6-2ed2-4a3c-bf6d-33bd0a374efa	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENALAPRIL MALEATE generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Golden State Medical Supply, Inc.	074fe718-88d8-365c-e063-6394a90a299d	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Preferred Pharmaceuticals Inc.	b31372f7-cda3-4ead-a481-4cde62e843fd	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENALAPRIL MALEATE generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Sun Pharmaceutical Industries, Inc.	f103b9f9-e081-419d-a2d8-b86acda834dd	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Preferred Pharmaceuticals Inc.	eee8633b-9d9e-453d-8c6b-8b13c94d2f58	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENALAPRIL MALEATE generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATE	ENALAPRIL MALEATE	ScieGen Pharmaceuticals, Inc.	63187a94-9ac7-4320-ac70-0631e08c2b8d	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENALAPRIL MALEATE generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	St. Mary's Medical Park Pharmacy	ed266486-e4a5-9dd1-e053-2a95a90a80d3	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Bryant Ranch Prepack	c1e4cd79-ece5-432c-bd3a-ed4633ccec70	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENALAPRIL MALEATE generic name: ENALAPRIL MALEATE

Documents#

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