Application 078056

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

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
A078056-001	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13
A078056-002	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13
A078056-003	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13
A078056-004	ALPRAZOLAM	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078056-001	AB
A078056-002	AB
A078056-003	AB
A078056-004	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	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-001	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-002	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-003	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-004	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-02-13	`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	A078056-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078056-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078056-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078056-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078056-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078056-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078056-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078056-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078056-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078056-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078056-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078056-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078056-004	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam Extended Release	ALPRAZOLAM	Bryant Ranch Prepack	29477df1-68aa-44b3-bf9e-80ecff6ce879	2024-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078056 application number: ANDA078056 ndc (product): 71335-1129
Alprazolam Extended Release	ALPRAZOLAM	Bryant Ranch Prepack	4f6e4656-689f-46a6-a8ed-54ee55583357	2023-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078056 application number: ANDA078056

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-3083	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3083	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3083	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3083	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3084	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3084	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3084	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3084	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3086	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3086	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3086	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3086	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3087	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3087	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3087	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-3087	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
63629-5364	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
63629-5364	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
68788-6943	Alprazolam	Alprazolam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6943	Alprazolam	Alprazolam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6943	Alprazolam	Alprazolam	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0427	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0427	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-1129	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-1129	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current