Application 076045

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORAZEPAM	LORAZEPAM	TABLET;ORAL	0.5MG	No	No
002	LORAZEPAM	LORAZEPAM	TABLET;ORAL	1MG	No	No
003	LORAZEPAM	LORAZEPAM	TABLET;ORAL	2MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076045-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29
A076045-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29
A076045-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076045-001	AB
A076045-002	AB
A076045-003	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 4 · 126 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	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2001-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2001-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076045-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2001-08-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 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	A076045-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076045-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076045-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076045-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076045-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076045-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076045-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076045-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076045-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076045-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076045-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076045-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076045-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076045-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076045-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076045-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076045-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076045-001	AB	1	`1e350fbaab3a…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	1f79a5a1-0c40-45cf-8994-51f5ba3a5938	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	86630bdd-13ad-4ab5-9e94-fcf2ea2113e1	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	08a30230-fc95-9025-e063-6394a90ae21b	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	17919c82-87f2-5030-e063-6294a90ac91a	2025-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1791d5c9-9004-5c4b-e063-6294a90adf3d	2025-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	29f63525-2839-946c-e063-6294a90aebb1	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Asclemed USA, Inc.	ebdf72f7-7462-4b83-81b4-c7988860c728	2024-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1bcf608a-11c1-ec7d-e063-6394a90ab710	2024-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	82f79757-69f0-4a37-93a6-55b66ae86ad7	2024-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	0ce02d7d-d855-c73f-e063-6294a90abe93	2023-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045
Lorazepam	LORAZEPAM	SUN PHARMACEUTICAL INDUSTRIES INC	0c1caa9c-9ef1-459c-86c3-adb939130a9f	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076045 application number: ANDA076045 ndc (product): 63304-774 ndc (product): 63304-772 ndc (product): 63304-773

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-085	Lorazepam	Lorazepam	Blenheim Pharmacal, Inc.	ANDA	Current
12634-867	Lorazepam	Lorazepam	Apotheca, Inc	ANDA	Current
33358-221	Lorazepam	Lorazepam	RxChange Co.	ANDA	Current
63304-772	Lorazepam	Lorazepam	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-773	Lorazepam	Lorazepam	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-774	Lorazepam	Lorazepam	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
64725-0772	Lorazepam	Lorazepam	TYA Pharmaceuticals	ANDA	Current
64725-0773	Lorazepam	Lorazepam	TYA Pharmaceuticals	ANDA	Current
68788-9839	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9840	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8855	ORIG	2003-04-15