Application 075317

Type: ANDA
Sponsor: JUBILANT CADISTA

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 44.

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	RLD / RS	Approval date
A075317-001	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20
A075317-002	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20
A075317-003	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20
A075317-004	TERAZOSIN HYDROCHLORIDE	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075317-001	AB
A075317-002	AB
A075317-003	AB
A075317-004	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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-001	TERAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL	AB	RS	2004-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-002	TERAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2004-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-003	TERAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE / ORAL	AB		2004-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-004	TERAZOSIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		2004-12-20	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A075317-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075317-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075317-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075317-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075317-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075317-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075317-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075317-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075317-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075317-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075317-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075317-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075317-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075317-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075317-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075317-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075317-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075317-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075317-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075317-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075317-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075317-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075317-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075317-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075317-004	AB	1	`2680178bc6a6…`

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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terazosin	TERAZOSIN HYDROCHLORIDE	Proficient Rx LP	6cbd8853-718d-42ba-bc27-e3983eefb804	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	81d5422c-ff57-4f6d-927c-5de4dd7e1169	2021-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317 ndc (product): 71610-503 ndc (product): 71610-510
Terazosin	TERAZOSIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	0d7779b3-02c5-4a74-a749-82ed6ae2c9bc	2020-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075317 application number: ANDA075317 ndc (product): 71610-478

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 2 of 2 · 124 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67296-1264	Terazosin	Terazosin	RedPharm Drug, Inc.	ANDA	Current
67296-1264	Terazosin	Terazosin	RedPharm Drug, Inc.	ANDA	Current
67296-1264	Terazosin	Terazosin	RedPharm Drug, Inc.	ANDA	Current
67544-562	Terazosin hydrochloride	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-562	Terazosin hydrochloride	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-563	Terazosin hydrochloride	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-563	Terazosin hydrochloride	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-564	Terazosin hydrochloride	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-564	Terazosin hydrochloride	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-581	Terazosin hydrochloride	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-581	Terazosin hydrochloride	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68788-9815	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals	ANDA	Current
68788-9815	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9815	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9815	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9815	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9816	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals	ANDA	Current
68788-9816	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9816	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9816	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9816	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9817	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals	ANDA	Current
68788-9817	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9817	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9817	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9817	Terazosin hydrochloride	Terazosin hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current
70518-0074	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0074	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0074	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0074	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0317	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0342	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0342	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0342	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0342	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1875	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1875	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1875	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3114	Terazosin	Terazosin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-552	Terazosin	Terazosin Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71610-478	Terazosin	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-503	Terazosin	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-510	Terazosin	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-546	Terazosin	Terazosin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current