Application 072927

Type: ANDA
Sponsor: WATSON LABS

Application Products#

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072927-001	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB		1991-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072927-001	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 2 · 42 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	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072927-001	LORAZEPAM	1MG	TABLET / ORAL	AB	1991-10-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A072927-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072927-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072927-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072927-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072927-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072927-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072927-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072927-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072927-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072927-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072927-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072927-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072927-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072927-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072927-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072927-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072927-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072927-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072927-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072927-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072927-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072927-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072927-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072927-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072927-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072927-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072927-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072927-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072927-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072927-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072927-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072927-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072927-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072927-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072927-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072927-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072927-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072927-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072927-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072927-001	AB	1	`e64feba35796…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	6c5356b1-c199-49ad-bb00-fd67c6691f74	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927 ndc (product): 70518-3423
Lorazepam	LORAZEPAM	Coupler LLC	54d72943-f8d1-5a78-e063-6294a90a059b	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927
Lorazepam	LORAZEPAM	Redpharm Drug	52614947-c96c-3361-e063-6394a90ae172	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927
Lorazepam	LORAZEPAM	PD-Rx Pharmaceuticals, Inc.	7afd9a59-3463-4eda-8cf3-ef90be05de3d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927 ndc (product): 72789-226
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	3c20c89f-c8c3-43b3-837e-da413f449795	2025-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927 ndc (product): 71610-674
Lorazepam	LORAZEPAM	Golden State Medical Supply, Inc.	32fb5628-bf80-0135-e063-6294a90aa3ab	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927
Lorazepam	LORAZEPAM	Teva Pharmaceuticals USA, Inc.	1bf22e97-9425-484d-bac6-519c6bae6a37	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072927 application number: ANDA072927 ndc (product): 0093-3426

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 82 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3426	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3426	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3426	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3426	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0241	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
10544-244	Lorazepam	Lorazepam	Blenheim Pharmacal, Inc.	ANDA	Current
43063-048	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-048	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-048	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-048	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-048	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-048	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-048	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
49999-122	Lorazepam	Lorazepam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0272	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-0272	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-0272	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-0272	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-0272	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-0273	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-0273	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-0273	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-0273	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-4001	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50090-4191	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
50436-3960	Lorazepam	Lorazepam	Unit Dose Services	ANDA	Current
51655-822	Lorazepam	Lorazepam	Northwind Pharmaceuticals	ANDA	Current
53002-5290	Lorazepam	Lorazepam	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-5290	Lorazepam	Lorazepam	RPK Pharmaceuticals, Inc.	ANDA	Current
55154-1482	Lorazepam	Lorazepam	Cardinal Health	ANDA	Current
55154-1482	Lorazepam	Lorazepam	Cardinal Health	ANDA	Current
55289-487	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-487	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-487	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-487	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-487	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-487	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-487	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-487	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60687-355	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-355	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-355	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-355	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-355	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-355	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-638	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-638	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
63629-1233	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
63629-8174	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
63629-8174	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
63739-500	Lorazepam	Lorazepam	McKesson Corporation	ANDA	Current
63739-500	Lorazepam	Lorazepam	McKesson Corporation dba SKY Packaging	ANDA	Current
67296-0306	LORAZEPAM	lorazepam	RedPharm Drug Inc.	ANDA	Current
67544-261	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68071-5048	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5048	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5061	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5061	Lorazepam	Lorazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-0241	Lorazepam	Lorazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1431	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
70518-1431	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
70518-2239	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
70518-2239	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
70518-2239	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
70518-3423	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
71610-674	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-674	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-674	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72789-226	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-226	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current