Application 074342

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALPRAZOLAM	ALPRAZOLAM	TABLET;ORAL	0.25MG	No	No
002	ALPRAZOLAM	ALPRAZOLAM	TABLET;ORAL	0.5MG	No	No
003	ALPRAZOLAM	ALPRAZOLAM	TABLET;ORAL	1MG	No	No
004	ALPRAZOLAM	ALPRAZOLAM	TABLET;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
A074342-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31
A074342-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31
A074342-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31
A074342-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074342-001	AB
A074342-002	AB
A074342-003	AB
A074342-004	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	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`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	A074342-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074342-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074342-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-004	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	A-S Medication Solutions	8ef75d22-4a7c-48d5-a532-5a43b8593e7c	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	5040e1ed-32d6-4757-a0ee-b8240f3e7cf5	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	2f16ff78-1262-4bb8-9a25-822c13c4746f	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	b39e2bc8-b68f-0f4e-e053-2995a90a00fd	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342 ndc (product): 80425-0099
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	b4cd647f-1ba3-334e-e053-2995a90af352	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342 ndc (product): 80425-0110
Alprazolam	ALPRAZOLAM	Quality Care Products, LLC	8be0bc5e-3566-4fbd-a27d-634e64fd6d78	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	aaf7979c-168a-0da2-e053-2995a90a4d12	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	b43df4ca-8d28-7b3a-e053-2a95a90aa4d7	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	8ca8e0fc-6c3d-48d4-ad04-708182b45350	2024-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	25781f50-d309-4c4f-9e21-c019e068d101	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Actavis Pharma, Inc.	a23063c0-099a-4256-b95f-3a857bbf704b	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	29ddd9f2-c116-467b-8db3-38166482aea0	2018-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	2717699a-c8b6-4590-937a-cb86eadc5296	2018-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 86 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
80425-0099	Alprazolam	Alprazolam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0099	Alprazolam	Alprazolam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0110	Xanax	Alprazolam 1mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0110	Alprazolam	Alprazolam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0110	Alprazolam	Alprazolam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0110	Alprazolam	Alprazolam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current