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 3 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	A-S Medication Solutions	fd0a7ecc-d6a2-4e04-a14f-1ed4dacb7df3	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENALAPRIL MALEATE generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Rising Pharma Holdings, Inc.	71e9fff3-7283-437e-b107-72fc16f09989	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENALAPRIL MALEATE generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	ec6c8c65-b438-40e3-9eb3-665d939abbdb	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	2e4ecc3a-ec6d-418b-99a8-95ad3e1c59d6	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	4f56955c-fc61-49ad-b42f-ff9d3386af6a	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	NuCare Pharmaceuticals,Inc.	fd013f06-3456-c178-e053-6294a90a6bd9	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	NuCare Pharmaceuticals,Inc.	0b3dbe11-ff75-cb98-e063-6294a90ad2e9	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Northstar RxLLC	e109e7b1-4650-4416-9d89-7c1185d5cf48	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Coupler LLC	2cc892e2-1d91-e52a-e063-6394a90a6649	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	NuCare Pharmaceuticals,Inc.	fe2dfa84-0276-6603-e053-6394a90af8ee	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	dfc439f7-83f5-4b9e-bbf2-f3d002860be3	2024-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	Chartwell RX, LLC	b1df1832-dce4-443f-87fc-e4177d069035	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Enalapril maleate generic name: ENALAPRIL MALEATE
Enalapril maleate oral solution	ENALAPRIL MALEATE	Bionpharma Inc.	9391b8d8-2217-4838-8976-1a5ad90ef4ca	2024-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril maleate oral solution	ENALAPRIL MALEATE	NorthStar RxLLC	19606da3-c6b0-40a5-9690-77fc37072b51	2024-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Bryant Ranch Prepack	2061543d-67e7-46b6-aa56-cafa11ae4b93	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
ENALAPRIL MALEATE	ENALAPRIL MALEATE	Aurobindo Pharma Limited	337707cc-4ed9-4121-bfff-c5015e5eca9d	2024-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ENALAPRIL MALEATE generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	0ad4bfb4-62db-4759-af60-88eb031d125a	2023-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	f3754f29-9b75-4e2c-9c28-b3479f5bf906	2023-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	A-S Medication Solutions	7b80abb4-fa75-48a4-a2e9-b0e31205234c	2023-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril maleate	ENALAPRIL MALEATE	A-S Medication Solutions	ccdd0f67-e9d5-41e3-93d5-94b9792a6f8f	2023-04-27	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