Application 078561

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALPRAZOLAM	ALPRAZOLAM	TABLET, ORALLY DISINTEGRATING;ORAL	0.25MG	No	No
002	ALPRAZOLAM	ALPRAZOLAM	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	No	No
003	ALPRAZOLAM	ALPRAZOLAM	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	No	No
004	ALPRAZOLAM	ALPRAZOLAM	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078561-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16
A078561-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16
A078561-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16
A078561-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078561-001	AB
A078561-002	AB
A078561-003	AB
A078561-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A078561-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078561-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078561-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078561-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078561-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078561-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078561-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078561-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078561-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078561-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078561-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078561-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078561-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078561-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078561-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078561-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078561-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078561-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078561-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078561-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078561-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078561-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078561-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078561-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078561-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078561-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078561-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078561-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078561-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078561-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078561-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078561-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078561-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078561-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078561-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078561-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078561-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078561-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078561-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078561-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2010-03-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078561-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078561-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078561-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078561-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078561-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078561-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078561-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078561-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078561-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078561-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078561-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078561-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078561-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078561-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078561-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078561-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078561-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078561-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078561-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078561-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078561-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078561-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078561-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078561-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078561-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078561-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078561-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078561-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078561-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078561-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078561-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078561-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078561-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078561-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078561-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078561-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078561-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078561-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078561-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078561-004	AB	1	`d06236e962d9…`

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	Actavis Pharma, Inc.	5ceed721-2e65-4c81-bd84-f110b1ac9d2e	2022-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078561 application number: ANDA078561 ndc (product): 0228-4022 ndc (product): 0228-4025 ndc (product): 0228-4024 ndc (product): 0228-4019

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-4019	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4019	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4019	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4019	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4019	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4019	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4022	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4022	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4022	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4022	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4022	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4022	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4024	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4024	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4024	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4024	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4024	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4024	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4025	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4025	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4025	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4025	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4025	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current
0228-4025	Alprazolam	Alprazolam	Actavis Pharma, Inc.	ANDA	Current