Application 074823

Type: ANDA
Sponsor: APNAR PHARMA LP

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	Yes
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 1.

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
A074823-001	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30
A074823-002	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30
A074823-003	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30
A074823-004	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074823-001	AB
A074823-002	AB
A074823-003	AB
A074823-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A074823-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074823-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074823-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074823-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074823-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074823-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074823-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074823-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074823-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	1998-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074823-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	1998-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074823-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB	1998-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074823-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1998-03-30	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074823-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074823-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074823-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074823-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074823-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074823-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074823-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074823-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074823-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074823-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074823-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074823-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074823-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074823-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074823-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074823-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074823-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074823-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074823-004	AB	1	`d06236e962d9…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terazosin Hydrochloride	TERAZOSIN HYDROCHLORIDE	Amerisyn, LLC	5680d373-0f61-baf8-e063-6394a90ab8a6	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074823 application number: ANDA074823
Terazosin Hydrochloride	TERAZOSIN HYDROCHLORIDE	Amici Pharma, Inc.	4007dbd3-e850-43e7-8a56-8735e31063cd	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074823 application number: ANDA074823
Terazosin Hydrochloride	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	214d9b06-8d23-3ee8-e063-6394a90a1521	2024-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074823 application number: ANDA074823
Terazosin Hydrochloride	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	9199083d-403f-4c9e-90e1-713ed0a07903	2023-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074823 application number: ANDA074823
Terazosin Hydrochloride	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e5507ea6-bdb3-4363-a68b-0478cbb25f4a	2021-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074823 application number: ANDA074823 ndc (product): 71610-595 ndc (product): 71610-594

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1337	Terazosin Hydrochloride	Terazosin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1338	Terazosin	Terazosin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1339	Terazosin	Terazosin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0781-2051	Terazosin Hydrochloride	Terazosin Hydrochloride	Sandoz Inc	ANDA	Current
0781-2052	Terazosin Hydrochloride	Terazosin Hydrochloride	Sandoz Inc	ANDA	Current
0781-2053	Terazosin Hydrochloride	Terazosin Hydrochloride	Sandoz Inc	ANDA	Current
0781-2054	Terazosin Hydrochloride	Terazosin Hydrochloride	Sandoz Inc	ANDA	Current
0904-6126	Terazosin Hydrochloride	Terazosin Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6127	Terazosin Hydrochloride	Terazosin Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6128	Terazosin Hydrochloride	Terazosin Hydrochloride	Major Pharmaceuticals	ANDA	Current
24689-792	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-792	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-792	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-855	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-855	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-855	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-882	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-882	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-882	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-961	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-961	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
24689-961	Terazosin Hydrochloride	Terazosin Hydrochloride	Apnar Pharma LP	ANDA	Current
50090-0659	Terazosin Hydrochloride	Terazosin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0659	Terazosin Hydrochloride	Terazosin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0659	Terazosin Hydrochloride	Terazosin Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-4247	Terazosin Hydrochloride	Terazosin Hydrochloride	Unit Dose Services	ANDA	Current
70518-0821	Terazosin Hydrochloride	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0821	Terazosin Hydrochloride	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-2125	Terazosin Hydrochloride	Terazosin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-594	Terazosin Hydrochloride	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-595	Terazosin Hydrochloride	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22375	ORIG	1998-03-30