Application 072928

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	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072928-001	LORAZEPAM	LORAZEPAM	2MG	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
A072928-001	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	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072928-001	LORAZEPAM	2MG	TABLET / ORAL	AB	1991-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072928-001	LORAZEPAM	2MG	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	A072928-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072928-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072928-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072928-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072928-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072928-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072928-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072928-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072928-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072928-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072928-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072928-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072928-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072928-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072928-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072928-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072928-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072928-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072928-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072928-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072928-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072928-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072928-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072928-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072928-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072928-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072928-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072928-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072928-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072928-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072928-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072928-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072928-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072928-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072928-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072928-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072928-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072928-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072928-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072928-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	ed37d304-04cf-43ec-a58d-d72002ff889b	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928 ndc (product): 70518-3188
Lorazepam	LORAZEPAM	Unit Dose Solutions, Inc.	551a1b7f-d342-2c53-e063-6394a90a9a2a	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928
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): 072928 application number: ANDA072928 ndc (product): 71610-655
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): 072928 application number: ANDA072928
Lorazepam	LORAZEPAM	Teva Pharmaceuticals USA, Inc.	1bf22e97-9425-484d-bac6-519c6bae6a37	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072928 application number: ANDA072928 ndc (product): 0093-3427

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3427	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3427	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3427	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3427	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3427	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3427	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3427	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3427	Lorazepam	Lorazepam	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
0591-0242	Lorazepam	Lorazepam	Actavis Pharma, Inc.	ANDA	Current
50090-4157	Lorazepam	Lorazepam	A-S Medication Solutions	ANDA	Current
55289-594	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-594	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-594	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-594	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-594	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60687-367	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-367	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-367	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-367	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-627	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-649	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-649	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-649	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-649	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
60687-649	Lorazepam	Lorazepam	American Health Packaging	ANDA	Current
63739-501	Lorazepam	Lorazepam	McKesson Corporation	ANDA	Current
63739-501	Lorazepam	Lorazepam	McKesson Corporation dba SKY Packaging	ANDA	Current
64725-0242	Lorazepam	Lorazepam	TYA Pharmaceuticals	ANDA	Current
67544-142	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
70518-2799	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
70518-2799	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
70518-3188	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
71610-655	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-655	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-655	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-655	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-655	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-655	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current