Application 075788

Type: ANDA
Sponsor: TARO PHARM INDS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	5MG;12.5MG	No	No
002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	10MG;25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB		2001-09-18
A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB		2001-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075788-001	AB
A075788-002	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 3 · 84 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	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075788-001	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	5MG;12.5MG	TABLET / ORAL	AB	2001-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075788-002	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	10MG;25MG	TABLET / ORAL	AB	2001-09-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A075788-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075788-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075788-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075788-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075788-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075788-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075788-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075788-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075788-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075788-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075788-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075788-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075788-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075788-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075788-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075788-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075788-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075788-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075788-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075788-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075788-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075788-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075788-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075788-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075788-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075788-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075788-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075788-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075788-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075788-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075788-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075788-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075788-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075788-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075788-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075788-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075788-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075788-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075788-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075788-002	AB	1	`bb7c543d1eb4…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enalapril Maleate and Hydrochlorothiazide	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	Sun Pharmaceutical Industries, Inc.	7cb92cf2-46f2-4379-937c-168d230e43a4	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075788 application number: ANDA075788 ndc (product): 51672-4045 ndc (product): 51672-4046

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-780	Enalapril Maleate and Hydrochlorothiazide	Enalapril Maleate and Hydrochlorothiazide	Rebel Distributors Corp	ANDA	Current
51672-4045	Enalapril Maleate and Hydrochlorothiazide	Enalapril Maleate and Hydrochlorothiazide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4045	Enalapril Maleate and Hydrochlorothiazide	Enalapril Maleate and Hydrochlorothiazide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4046	Enalapril Maleate and Hydrochlorothiazide	Enalapril Maleate and Hydrochlorothiazide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4046	Enalapril Maleate and Hydrochlorothiazide	Enalapril Maleate and Hydrochlorothiazide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
68071-4144	Enalapril Maleate and Hydrochlorothiazide	Enalapril Maleate and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4144	Enalapril Maleate and Hydrochlorothiazide	Enalapril Maleate and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8789	ORIG	2004-06-24
8790	ORIG	2004-06-03