Application 077657

Type: ANDA
Sponsor: MYLAN

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 44.

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	Approval date
A077657-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16
A077657-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16
A077657-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16

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 3 of 4 · 132 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
2020-11-12 02:37 UTC	2020-11	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-03-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-03-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-03-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-03-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-03-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-03-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-03-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-03-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-03-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-03-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077657-002	LORAZEPAM	1MG	TABLET / ORAL		2006-03-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-03-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077657-002	LORAZEPAM	1MG	TABLET / ORAL		2006-03-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-03-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077657-002	LORAZEPAM	1MG	TABLET / ORAL		2006-03-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-03-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077657-002	LORAZEPAM	1MG	TABLET / ORAL		2006-03-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-03-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077657-002	LORAZEPAM	1MG	TABLET / ORAL		2006-03-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-03-16	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077657-002	LORAZEPAM	1MG	TABLET / ORAL		2006-03-16	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-03-16	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077657-002	LORAZEPAM	1MG	TABLET / ORAL		2006-03-16	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-03-16	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077657-002	LORAZEPAM	1MG	TABLET / ORAL		2006-03-16	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-03-16	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077657-002	LORAZEPAM	1MG	TABLET / ORAL		2006-03-16	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-03-16	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077657-002	LORAZEPAM	1MG	TABLET / ORAL		2006-03-16	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077657-003	LORAZEPAM	2MG	TABLET / ORAL		2006-03-16	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077657-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077657-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077657-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077657-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077657-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077657-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077657-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077657-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077657-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077657-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077657-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077657-003	AB	1	`ea99ee380514…`

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 6 · 101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Clinical Solutions Wholesale, LLC	c0810422-b732-4c04-97d8-c1521c401ef4	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	86630bdd-13ad-4ab5-9e94-fcf2ea2113e1	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	5a02c97d-637d-43f7-803c-afe4381ccc59	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	6c5356b1-c199-49ad-bb00-fd67c6691f74	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	ed37d304-04cf-43ec-a58d-d72002ff889b	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	Preferred Pharmaceuticals Inc.	903351ae-1bb0-4ac0-8430-df24cf2eee76	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	be9f8bda-1cd9-40a6-a4da-b5961389fb5b	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	ANI Pharmaceuticals, Inc.	787240e9-67b5-4af3-b16d-7cf314e3f2e3	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Hospira, Inc.	20140b19-846b-425f-b191-670e17809945	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	d6364be4-056b-4ebe-83bc-3fc85e8f488c	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	St. Mary's Medical Park Pharmacy	56093df3-10f6-e747-e063-6294a90a6564	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	St. Mary's Medical Park Pharmacy	569e8a5a-ddf7-ebbc-e063-6294a90ab7a4	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	b707ecb2-644c-4323-ab0e-7bc5929cd560	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Unit Dose Solutions, Inc.	5519bba8-9eb7-a3e0-e063-6294a90afd94	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Unit Dose Solutions, Inc.	551a1b7f-d342-2c53-e063-6394a90a9a2a	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	REMEDYREPACK INC.	0cd02e52-ead5-4b2a-9708-c7c4be7b7995	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Coupler LLC	54d72943-f8d1-5a78-e063-6294a90a059b	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Redpharm Drug	5407f327-3a22-8c15-e063-6294a90a3169	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	REMEDYREPACK INC.	7fa1a011-5e28-4b13-bcd2-5c5fc9b663b2	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	Bryant Ranch Prepack	46af8e93-3169-408a-b4d8-b8498642801d	2026-06-05	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 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2321	Lorazepam	lorazepam	Mylan Pharmaceuticals Inc	ANDA	Current
0378-2321	Lorazepam	lorazepam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2457	Lorazepam	lorazepam	Mylan Pharmaceuticals Inc	ANDA	Current
0378-2457	Lorazepam	lorazepam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2777	Lorazepam	lorazepam	Mylan Pharmaceuticals Inc	ANDA	Current
0378-2777	Lorazepam	lorazepam	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-7805	Lorazepam	lorazepam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
35356-844	Lorazepam	lorazepam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-3093	Lorazepam	lorazepam	A-S Medication Solutions	ANDA	Current
50090-3146	Lorazepam	lorazepam	A-S Medication Solutions	ANDA	Current
51079-386	Lorazepam	lorazepam	Mylan Institutional Inc.	ANDA	Current
51079-387	Lorazepam	lorazepam	Mylan Institutional Inc.	ANDA	Current
51079-417	Lorazepam	lorazepam	Mylan Institutional Inc.	ANDA	Current
53002-7720	Lorazepam	lorazepam	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7720	Lorazepam	lorazepam	RPK Pharmaceuticals, Inc.	ANDA	Current
55154-5550	Lorazepam	lorazepam	Cardinal Health	ANDA	Current
55154-5550	Lorazepam	lorazepam	Cardinal Health	ANDA	Current
55154-5590	Lorazepam	lorazepam	Cardinal Health	ANDA	Current
55154-5590	Lorazepam	lorazepam	Cardinal Health	ANDA	Current
55154-5655	Lorazepam	lorazepam	Cardinal Health	ANDA	Current
55154-5655	Lorazepam	lorazepam	Cardinal Health	ANDA	Current
63187-208	Lorazepam	lorazepam	Proficient Rx LP	ANDA	Current
63187-208	Lorazepam	lorazepam	Proficient Rx LP	ANDA	Current
63187-417	Lorazepam	lorazepam	Proficient Rx LP	ANDA	Current
63187-417	Lorazepam	lorazepam	Proficient Rx LP	ANDA	Current
63187-868	Lorazepam	lorazepam	Proficient Rx LP	ANDA	Current
63187-868	Lorazepam	lorazepam	Proficient Rx LP	ANDA	Current
67296-0726	Lorazepam	lorazepam	RedPharm Inc.	ANDA	Current
67544-870	Lorazepam	lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-879	Lorazepam	lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-982	Lorazepam	lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
70518-0155	Lorazepam	lorazepam	REMEDYREPACK INC.	ANDA	Current
70518-0156	Lorazepam	lorazepam	REMEDYREPACK INC.	ANDA	Current