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 4 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enalapril maleate oral solution	ENALAPRIL MALEATE	Camber Pharmaceuticals, Inc.	b63bdaa6-b57b-417b-9a79-29f1fd5bbf08	2022-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	OCEANSIDE PHARMACEUTICALS	ebd2a62d-a704-4f8a-a104-749a5296502f	2020-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Proficient Rx LP	ca1d0143-bbd3-4041-9981-eadbb8893a2b	2020-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL MALEATE	Proficient Rx LP	cc921315-8da1-487c-ba19-433470f5c8d8	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Enalapril Maleate generic name: ENALAPRIL MALEATE
Enalapril Maleate	ENALAPRIL	Amneal Pharmaceuticals NY LLC	e81a8aca-0e7c-4a02-b596-09e4ac22c70e	2019-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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