Application 078387

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALPRAZOLAM	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	0.5MG	No	No
002	ALPRAZOLAM	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	1MG	No	No
003	ALPRAZOLAM	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	2MG	No	No
004	ALPRAZOLAM	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	3MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078387-001	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30
A078387-002	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30
A078387-003	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30
A078387-004	ALPRAZOLAM	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078387-001	AB
A078387-002	AB
A078387-003	AB
A078387-004	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 5 · 168 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	A078387-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078387-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078387-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078387-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078387-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078387-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078387-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078387-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078387-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078387-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078387-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078387-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078387-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078387-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078387-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078387-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078387-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078387-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078387-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078387-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078387-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078387-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078387-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078387-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078387-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078387-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078387-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078387-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078387-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078387-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078387-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078387-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078387-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078387-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078387-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078387-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078387-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078387-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078387-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078387-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-05-30	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078387-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078387-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078387-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078387-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078387-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078387-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078387-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078387-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078387-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078387-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078387-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078387-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078387-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078387-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078387-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078387-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078387-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078387-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078387-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078387-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078387-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078387-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078387-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078387-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078387-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078387-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078387-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078387-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078387-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078387-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078387-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078387-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078387-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078387-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078387-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078387-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078387-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078387-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078387-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078387-004	AB	1	`d8e5a09893c0…`

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
Alprazolam	ALPRAZOLAM	Amneal Pharmaceuticals LLC	259387c1-e374-4bc2-9510-5f7f2c60d1a5	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078387 application number: ANDA078387 ndc (product): 65162-812 ndc (product): 65162-809 ndc (product): 65162-813 ndc (product): 65162-810

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-602	Alprazolam	Alprazolam	Rebel Distributors Corp.	ANDA	Current
21695-603	Alprazolam	Alprazolam	Rebel Distributors Corp.	ANDA	Current
21695-604	Alprazolam	Alprazolam	Rebel Distributors Corp.	ANDA	Current
21695-605	Alprazolam	Alprazolam	Rebel Distributors Corp.	ANDA	Current
33261-741	Alprazolam	Alprazolam	Aidarex Pharmaceuticals LLC	ANDA	Current
65162-809	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-809	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-809	Alprazolam	Alprazolam	Amneal Pharmaceuticals, LLC	ANDA	Current
65162-809	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-809	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-810	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-810	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-810	Alprazolam	Alprazolam	Amneal Pharmaceuticals, LLC	ANDA	Current
65162-810	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-810	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-812	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-812	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-812	Alprazolam	Alprazolam	Amneal Pharmaceuticals, LLC	ANDA	Current
65162-812	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-812	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-813	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-813	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-813	Alprazolam	Alprazolam	Amneal Pharmaceuticals, LLC	ANDA	Current
65162-813	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-813	Alprazolam	Alprazolam	Amneal Pharmaceuticals LLC	ANDA	Current
68788-9727	Alprazolam	Alprazolam	Preferred Pharmaceuticals, Inc.	ANDA	Current