Application 203572

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

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 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
A203572-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22
A203572-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22
A203572-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203572-001	AB
A203572-002	AB
A203572-003	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	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203572-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2017-12-22	`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	A203572-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203572-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203572-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203572-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203572-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203572-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203572-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203572-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203572-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203572-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203572-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203572-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203572-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203572-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203572-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203572-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203572-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203572-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203572-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203572-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203572-001	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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LORAZEPAM	LORAZEPAM	A-S Medication Solutions	823b1d71-a510-4d34-8015-60b55af23d78	2023-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572
Lorazepam	LORAZEPAM	Proficient Rx LP	5b78f7af-0ad8-4fa1-a8c0-9308fe8d9b3a	2022-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572 ndc (product): 71205-228
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1c956cc1-9217-46e0-80a3-7c811163d3f1	2021-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572 ndc (product): 71610-600
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	a4fa14be-cef1-4b4b-b099-abde92f15145	2019-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203572 application number: ANDA203572 ndc (product): 71610-199

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 · 77 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13107-083	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-083	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-083	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-083	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-083	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-084	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-084	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-084	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-084	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-084	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-085	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-085	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-085	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-085	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
13107-085	Lorazepam	Lorazepam	Aurolife Pharma, LLC	ANDA	Current
63629-8185	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
63629-8185	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
63629-8185	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
63629-8223	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
67046-888	Lorazepam	Lorazepam	Contract Pharmacy Services-PA	ANDA	Current
68071-4882	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4882	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4916	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4916	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4916	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4916	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4918	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4918	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5022	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5022	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5022	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5068	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5068	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5068	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5250	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5250	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5250	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5250	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5250	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5250	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7355	Lorazepam	Lorazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7355	Lorazepam	Lorazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7355	Lorazepam	Lorazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7355	Lorazepam	Lorazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7428	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7428	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7428	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7428	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7533	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7533	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7533	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7533	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
70934-782	Lorazepam	Lorazepam	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-228	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-228	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-228	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-228	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-228	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71335-1138	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1138	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1138	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1138	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1138	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1311	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1311	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1455	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1455	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1694	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1694	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1694	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1694	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71610-199	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-229	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-600	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-351	LORAZEPAM	LORAZEPAM	DirectRx	ANDA	Current
72189-351	LORAZEPAM	LORAZEPAM	DirectRx	ANDA	Current
72189-351	LORAZEPAM	LORAZEPAM	DirectRx	ANDA	Current