Application 075498

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 1MG BASE	No	No
002	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 2MG BASE	No	No
003	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE	No	No
004	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	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
A075498-001	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12
A075498-002	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12
A075498-003	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12
A075498-004	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12

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	A075498-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075498-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075498-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075498-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075498-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075498-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075498-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075498-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075498-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075498-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075498-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075498-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075498-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075498-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075498-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075498-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075498-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075498-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075498-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075498-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075498-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075498-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075498-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075498-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075498-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075498-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075498-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075498-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075498-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075498-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075498-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075498-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075498-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075498-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075498-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075498-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075498-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	2001-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075498-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	2001-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075498-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	2001-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075498-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2001-04-12	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075498-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075498-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075498-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075498-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075498-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075498-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075498-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075498-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075498-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075498-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075498-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075498-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075498-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075498-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075498-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075498-004	AB	1	`ea99ee380514…`

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terazosin	TERAZOSIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	40e5ae44-708a-15a3-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: TERAZOSIN HYDROCHLORIDE
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	363a6c85-e5e9-4521-9065-37a7c45bb525	2024-02-06	Warnings, Adverse reactions	Name fallback generic name: TERAZOSIN HYDROCHLORIDE
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	85e450c2-1bc3-49f4-ac2b-5aeedc154bba	2024-02-01	Warnings, Adverse reactions	Name fallback generic name: TERAZOSIN HYDROCHLORIDE
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	0574d9ae-04da-4cb2-b124-9d920012c411	2023-07-20	Warnings, Adverse reactions	Name fallback generic name: TERAZOSIN HYDROCHLORIDE
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2f2db826-182d-4dd1-af97-f874b57b1fb9	2023-06-15	Warnings, Adverse reactions	Name fallback generic name: TERAZOSIN HYDROCHLORIDE
Terazosin Hydrochloride	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	9199083d-403f-4c9e-90e1-713ed0a07903	2023-04-05	Warnings, Adverse reactions	Name fallback brand name: Terazosin Hydrochloride generic name: TERAZOSIN HYDROCHLORIDE
Terazosin	TERAZOSIN HYDROCHLORIDE	Proficient Rx LP	27f8952a-189d-4687-854e-c51da619bf3d	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: TERAZOSIN HYDROCHLORIDE
Terazosin	TERAZOSIN HYDROCHLORIDE	Proficient Rx LP	6cbd8853-718d-42ba-bc27-e3983eefb804	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: TERAZOSIN HYDROCHLORIDE
Terazosin Hydrochloride	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e5507ea6-bdb3-4363-a68b-0478cbb25f4a	2021-08-26	Warnings, Adverse reactions	Name fallback brand name: Terazosin Hydrochloride generic name: TERAZOSIN HYDROCHLORIDE
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	81d5422c-ff57-4f6d-927c-5de4dd7e1169	2021-01-22	Warnings, Adverse reactions	Name fallback generic name: TERAZOSIN HYDROCHLORIDE
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	0d7779b3-02c5-4a74-a749-82ed6ae2c9bc	2020-11-12	Warnings, Adverse reactions	Name fallback generic name: TERAZOSIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-289	Terazosin	Terazosin	Blenheim Pharmacal, Inc.	ANDA	Current
33261-211	Terazosin	Terazosin	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-212	Terazosin	Terazosin	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-870	Terazosin	Terazosin	Aidarex Pharmaceuticals LLC	ANDA	Current
53808-0306	Terazosin Hydrochloride	Terazosin Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0308	Terazosin Hydrochloride	Terazosin Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0930	Terazosin Hydrochloride	Terazosin Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
68788-9673	Terazosin	Terazosin	Preferred Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8695	ORIG	2001-04-12