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 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	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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077657-002	LORAZEPAM	1MG	TABLET / ORAL	2006-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077657-003	LORAZEPAM	2MG	TABLET / ORAL	2006-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077657-001	LORAZEPAM	0.5MG	TABLET / ORAL	2006-03-16	`301d65b070ca…`

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 4 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Chartwell RX, LLC	6b0619c5-b9e9-47e7-97b5-7e581e67cf5f	2024-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Asclemed USA, Inc.	ebdf72f7-7462-4b83-81b4-c7988860c728	2024-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8fa33078-c379-41f5-e053-2995a90acced	2024-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4a66b854-4dc1-3746-e054-00144ff8d46c	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	853c762d-0772-4f02-99ca-0bc2911f09f0	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4ab77192-8fe9-2965-e054-00144ff88e88	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	a4fe8df0-3ce8-b8b8-e053-2995a90a28f4	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	50379c41-2676-590c-e054-00144ff8d46c	2024-07-08	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1bcf608a-11c1-ec7d-e063-6394a90ab710	2024-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8aace309-f3ef-6aef-e053-2995a90aa197	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	933b5ef3-ec29-1a96-e053-2995a90a2d33	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	aac672f9-0ba7-4852-b8a7-caac9e4b1e77	2024-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Proficient Rx LP	e9052b38-3c9f-4c84-9a0d-98bd99b9ddfd	2024-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	e563594e-212c-4f31-92ea-294aeab45df3	2024-04-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	2024-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	e9b54e42-04cf-4c62-90e1-36f7b31a4e81	2024-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	ba34ddd2-9a47-48bf-8e55-f05e9085e5a8	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	8e3d44fb-24b7-4552-9e95-de3bf871a88b	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	International Medication Systems, Limited	7dda070d-7809-46c4-8592-eb4e4c509707	2024-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	82f79757-69f0-4a37-93a6-55b66ae86ad7	2024-02-06	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