Application 071194

Type: ANDA
Sponsor: SANDOZ

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 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
A071194-001	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL			1988-04-15

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071194-001	LORAZEPAM	1MG	TABLET / ORAL	1988-04-15	`f41ea6bd6efb…`

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 6 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	5ff82103-cc57-4af9-9362-82a7c686271d	2021-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	e83ae439-3fa5-453f-9073-4bf8c797df47	2019-03-26	Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	a4fa14be-cef1-4b4b-b099-abde92f15145	2019-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lorazepam generic name: LORAZEPAM
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f75	2018-11-05	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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-239	Lorazepam	Lorazepam	Rebel Distributors Corp	ANDA	Current
67296-0042	Lorazepam	Lorazepam	RedPharm Drug Inc.	ANDA	Current