Application 200169

Type: ANDA
Sponsor: HI-TECH PHARMA CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORAZEPAM	LORAZEPAM	CONCENTRATE;ORAL	2MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A200169-001	LORAZEPAM	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL			2012-01-30

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 · 43 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	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL		2012-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200169-001	LORAZEPAM	2MG/ML	CONCENTRATE / ORAL	AA	2012-01-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200169-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200169-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200169-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200169-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200169-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200169-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200169-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200169-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200169-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200169-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200169-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200169-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200169-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200169-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200169-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200169-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200169-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200169-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200169-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200169-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200169-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200169-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200169-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200169-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200169-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200169-001	AA	1	`cb3db0bc1861…`

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 3 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Rising Pharma Holdings, Inc.	386255e2-65aa-48ce-9eb1-246f1493cc14	2025-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals, Inc.	00960fbd-a5da-408b-9867-62982f20906f	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Preferred Pharmaceuticals, Inc.	6cc1f35d-ff33-404e-aa5e-b01eab89863e	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Ativan	LORAZEPAM	Bausch Health US LLC	89057c93-8155-4040-acec-64e877bd2b4c	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LORAZEPAM
LOREEV XR	LORAZEPAM	A-S Medication Solutions	c470fdee-8e18-4da9-b072-943d6b2518cf	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	3c20c89f-c8c3-43b3-837e-da413f449795	2025-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	17919c82-87f2-5030-e063-6294a90ac91a	2025-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Golden State Medical Supply, Inc.	32fb5628-bf80-0135-e063-6294a90aa3ab	2025-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1791d5c9-9004-5c4b-e063-6294a90adf3d	2025-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals,Inc.	8aaf9bcb-7a4e-ffaa-e053-2995a90a3913	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	DirectRx	ddcc0b2b-4be2-6d18-e053-2a95a90af987	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	4a66b854-4dd6-3746-e054-00144ff8d46c	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
LORAZEPAM	LORAZEPAM	Advanced Rx of Tennessee, LLC	2a57e549-390b-5482-e063-6394a90aeb3b	2024-12-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LORAZEPAM generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	29f63525-2839-946c-e063-6294a90aebb1	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Fresenius Kabi USA, LLC	b2487467-a63f-48b5-b0de-3a6ce6672d50	2024-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	NuCare Pharmaceuticals, Inc.	503834f9-fa2e-5e23-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	A-S Medication Solutions	be85b116-9f09-403a-8e0d-e77e344d3a9a	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
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

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-705	Lorazepam	Lorazepam	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-705	Lorazepam	Lorazepam	Akorn	ANDA	Current
50383-705	Lorazepam	Lorazepam	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-705	Lorazepam	Lorazepam	Hi-Tech Pharmacal Co., Inc.	ANDA	Current