Application 075479

Type: ANDA
Sponsor: HERITAGE PHARMA

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 42.

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	Approval date
A075479-001	ENALAPRIL MALEATE	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22
A075479-002	ENALAPRIL MALEATE	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22
A075479-003	ENALAPRIL MALEATE	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22
A075479-004	ENALAPRIL MALEATE	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075479-001	AB
A075479-002	AB
A075479-003	AB
A075479-004	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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-001	ENALAPRIL MALEATE	2.5MG	TABLET / ORAL	AB	2000-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-002	ENALAPRIL MALEATE	5MG	TABLET / ORAL	AB	2000-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-003	ENALAPRIL MALEATE	10MG	TABLET / ORAL	AB	2000-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-004	ENALAPRIL MALEATE	20MG	TABLET / ORAL	AB	2000-08-22	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075479-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075479-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075479-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075479-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075479-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075479-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075479-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075479-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075479-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075479-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075479-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075479-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075479-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075479-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075479-004	AB	1	`d8e5a09893c0…`

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 · 10 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	9f913e79-fe6d-4ff2-9f8e-eef9df689fa8	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Legacy Pharmaceutical Packaging, LLC	ed7536f1-9a7d-4519-e053-2a95a90a4a65	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479 ndc (product): 68645-607 ndc (product): 68645-605 ndc (product): 68645-606
Enalapril maleate	ENALAPRIL MALEATE	Major Pharmaceuticals	8fe8dc52-dee6-4d33-b798-e90128011f46	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	f29ef93b-7380-2196-e053-2995a90a2ce3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	f2a0bd73-0389-3f88-e053-2995a90a72e8	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Northwind Health Company, LLC	f2b3776b-02a1-311b-e053-2a95a90a2f9b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	5c49fb37-1f09-4965-b213-5580d3a30a11	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479 ndc (product): 23155-706 ndc (product): 23155-705 ndc (product): 23155-707 ndc (product): 23155-704 ndc (product): 23155-772 ndc (product): 23155-773
Enalapril maleate	ENALAPRIL MALEATE	REMEDYREPACK INC.	7077d32e-4b06-4d48-ba0c-6db2f8ebe08c	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	Chartwell RX, LLC	b1df1832-dce4-443f-87fc-e4177d069035	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479
Enalapril maleate	ENALAPRIL MALEATE	A-S Medication Solutions	ccdd0f67-e9d5-41e3-93d5-94b9792a6f8f	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075479 application number: ANDA075479

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-0026	Enalapril Maleate	Enalapril Maleate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0026	Enalapril Maleate	Enalapril Maleate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0027	Enalapril Maleate	Enalapril Maleate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0027	Enalapril Maleate	Enalapril Maleate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0028	Enalapril Maleate	Enalapril Maleate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0028	Enalapril Maleate	Enalapril Maleate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0029	Enalapril Maleate	Enalapril Maleate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0029	Enalapril Maleate	Enalapril Maleate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
23155-704	Enalapril maleate	Enalapril maleate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-704	Enalapril maleate	Enalapril maleate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-704	Enalapril maleate	Enalapril maleate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-705	Enalapril maleate	Enalapril maleate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-705	Enalapril maleate	Enalapril maleate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-705	Enalapril maleate	Enalapril maleate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-706	Enalapril maleate	Enalapril maleate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-707	enalapril maleate	enalapril maleate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-772	Enalapril maleate	Enalapril maleate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-773	Enalapril maleate	Enalapril maleate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
50090-3166	Enalapril Maleate	Enalapril Maleate	A-S Medication Solutions	ANDA	Current
53808-0648	Enalapril Maleate	Enalapril Maleate	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0663	Enalapril Maleate	Enalapril Maleate	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0833	Enalapril Maleate	Enalapril Maleate	State of Florida DOH Central Pharmacy	ANDA	Current
68071-3221	Enalapril Maleate	Enalapril Maleate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68645-605	Enalapril maleate	Enalapril maleate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-606	Enalapril maleate	Enalapril maleate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-607	Enalapril maleate	Enalapril maleate	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
69043-032	Enalapril maleate	Enalapril maleate	Cronus Pharma LLC	ANDA	Current
69043-033	Enalapril maleate	Enalapril maleate	Cronus Pharma LLC	ANDA	Current
69043-034	enalapril maleate	enalapril maleate	Cronus Pharma LLC	ANDA	Current
69043-035	Enalapril maleate	Enalapril maleate	Cronus Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30907	ORIG	2004-06-03
30906	ORIG	2000-08-22