Application 071141

Type: ANDA
Sponsor: SANDOZ

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A071141-001	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21
A071141-002	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21
A071141-003	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071141-001	AB
A071141-002	AB
A071141-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071141-002	LORAZEPAM	0.5MG	TABLET / ORAL	AB	1987-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071141-003	LORAZEPAM	1MG	TABLET / ORAL	AB	1987-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071141-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1987-04-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A071141-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071141-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071141-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071141-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071141-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071141-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071141-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071141-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071141-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071141-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071141-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071141-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071141-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071141-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071141-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071141-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071141-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071141-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071141-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071141-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071141-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071141-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071141-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071141-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071141-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071141-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071141-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071141-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071141-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071141-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071141-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071141-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071141-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071141-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071141-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071141-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071141-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071141-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071141-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071141-001	AB	1	`301d65b070ca…`

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 6 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	5ff82103-cc57-4af9-9362-82a7c686271d	2021-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	e83ae439-3fa5-453f-9073-4bf8c797df47	2019-03-26	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	a4fa14be-cef1-4b4b-b099-abde92f15145	2019-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f75	2018-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5371	Lorazepam	Lorazepam	Sandoz Inc	ANDA	Current
0781-5377	Lorazepam	Lorazepam	Sandoz Inc	ANDA	Current
0781-5379	Lorazepam	Lorazepam	Sandoz Inc	ANDA	Current
0781-5408	Lorazepam	Lorazepam	Sandoz Inc	ANDA	Current
45865-422	Lorazepam	Lorazepam	Medsource Pharmaceuticals	ANDA	Current
50090-3141	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-3462	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
52959-365	LORAZEPAM	LORAZEPAM	H.J. Harkins Company, Inc.	ANDA	Current
66267-608	Lorazepam	Lorazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-608	Lorazepam	Lorazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
66336-800	Lorazepam	Lorazepam	Dispensing Solutions, Inc.	ANDA	Current
67046-982	Lorazepam	Lorazepam	Contract Pharmacy Services-PA	ANDA	Current
68084-754	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
68788-7411	Lorazepam	Lorazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7411	Lorazepam	Lorazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-200	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-200	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71335-0277	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71610-148	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-149	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current