Application 077396

Type: ANDA
Sponsor: ANI PHARMS INC

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 42.

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	TE codes	Approval date
A077396-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-12-13
A077396-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-12-13
A077396-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077396-001	AB
A077396-002	AB
A077396-003	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 4 · 126 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	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077396-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077396-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077396-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077396-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077396-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077396-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077396-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077396-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077396-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077396-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077396-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077396-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077396-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077396-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2006-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077396-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2006-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077396-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2006-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077396-002	LORAZEPAM	1MG	TABLET / ORAL		2006-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077396-003	LORAZEPAM	2MG	TABLET / ORAL		2006-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077396-002	LORAZEPAM	1MG	TABLET / ORAL		2006-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077396-003	LORAZEPAM	2MG	TABLET / ORAL		2006-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077396-002	LORAZEPAM	1MG	TABLET / ORAL		2006-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077396-003	LORAZEPAM	2MG	TABLET / ORAL		2006-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077396-002	LORAZEPAM	1MG	TABLET / ORAL		2006-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077396-003	LORAZEPAM	2MG	TABLET / ORAL		2006-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077396-002	LORAZEPAM	1MG	TABLET / ORAL		2006-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077396-003	LORAZEPAM	2MG	TABLET / ORAL		2006-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077396-001	LORAZEPAM	0.5MG	TABLET / ORAL		2006-12-13	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077396-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077396-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077396-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077396-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077396-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077396-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077396-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077396-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077396-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077396-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077396-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077396-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077396-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077396-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077396-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077396-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077396-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077396-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077396-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077396-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077396-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077396-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077396-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077396-003	AB	1	`2680178bc6a6…`
2019-12-13 00:20 UTC	2019-12	A077396-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077396-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077396-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077396-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077396-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077396-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077396-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077396-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077396-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077396-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077396-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077396-003	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077396-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077396-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077396-003	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	ANI Pharmaceuticals, Inc.	787240e9-67b5-4af3-b16d-7cf314e3f2e3	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077396 application number: ANDA077396