Application 074174

Type: ANDA
Sponsor: DAVA INTL INC

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
A074174-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19
A074174-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19
A074174-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19
A074174-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074174-001	AB
A074174-002	AB
A074174-003	AB
A074174-004	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	A074174-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074174-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074174-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074174-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074174-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074174-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074174-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074174-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074174-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074174-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074174-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074174-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074174-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074174-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074174-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074174-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074174-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074174-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074174-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074174-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074174-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074174-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074174-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074174-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074174-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074174-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074174-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074174-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074174-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074174-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074174-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074174-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074174-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074174-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074174-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074174-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074174-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074174-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074174-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074174-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 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	A074174-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074174-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074174-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074174-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074174-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074174-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074174-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074174-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074174-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074174-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074174-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074174-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074174-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074174-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074174-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074174-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074174-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074174-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074174-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074174-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074174-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074174-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074174-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074174-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074174-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074174-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074174-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074174-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074174-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074174-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074174-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074174-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074174-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074174-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074174-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074174-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074174-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074174-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074174-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074174-004	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	ANI Pharmaceuticals, Inc.	38428a1b-718c-49cc-94ae-2e3644ba6256	2023-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074174 application number: ANDA074174 ndc (product): 70954-510 ndc (product): 70954-511 ndc (product): 70954-509 ndc (product): 70954-508

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 141 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67253-902	Alprazolam	Alprazolam	Par Pharmaceutical	ANDA	Current
67253-903	Alprazolam	Alprazolam	Par Pharmaceutical	ANDA	Current
67253-903	Alprazolam	Alprazolam	Par Pharmaceutical	ANDA	Current
67253-903	Alprazolam	Alprazolam	Par Pharmaceutical	ANDA	Current
67253-903	Alprazolam	Alprazolam	Par Pharmaceutical	ANDA	Current
67296-0721	Alprazolam	Alprazolam	RedPharm Drug, Inc.	ANDA	Current
67296-0721	Alprazolam	Alprazolam	RedPharm Drug, Inc.	ANDA	Current
67296-0958	Alprazolam	Alprazolam	RedPharm Drug, Inc.	ANDA	Current
67296-0958	Alprazolam	Alprazolam	RedPharm Drug, Inc.	ANDA	Current
67296-0958	Alprazolam	Alprazolam	RedPharm Drug, Inc.	ANDA	Current
68071-4447	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4447	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4621	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4621	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4652	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4652	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4652	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4818	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4818	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4855	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4855	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4923	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4923	Alprazolam	Alprazolam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6358	Alprazolam	Alprazolam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6358	Alprazolam	Alprazolam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6381	Alprazolam	Alprazolam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6381	Alprazolam	Alprazolam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9430	Alprazolam	Alprazolam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9430	Alprazolam	Alprazolam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9430	Alprazolam	Alprazolam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9430	Alprazolam	Alprazolam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9997	Alprazolam	Alprazolam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9997	Alprazolam	Alprazolam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9997	Alprazolam	Alprazolam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9997	Alprazolam	Alprazolam	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0966	Alprazolam	Alprazolam	REMEDYREPACK INC.	ANDA	Current
70518-0966	Alprazolam	Alprazolam	REMEDYREPACK INC.	ANDA	Current
70518-0966	Alprazolam	Alprazolam	REMEDYREPACK INC.	ANDA	Current
70954-508	Alprazolam	Alprazolam	Novitium Pharma LLC	ANDA	Current
70954-509	Alprazolam	Alprazolam	Novitium Pharma LLC	ANDA	Current
70954-510	Alprazolam	Alprazolam	Novitium Pharma LLC	ANDA	Current
70954-511	Alprazolam	Alprazolam	Novitium Pharma LLC	ANDA	Current
71205-290	Alprazolam	Alprazolam	Proficient Rx LP	ANDA	Current
71205-290	Alprazolam	Alprazolam	Proficient Rx LP	ANDA	Current
71205-386	Alprazolam	Alprazolam	Proficient Rx LP	ANDA	Current
71335-0673	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0673	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0673	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0673	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0680	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0680	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0680	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0680	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0761	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0761	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0813	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0813	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0813	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
71335-0813	Alprazolam	Alprazolam	Bryant Ranch Prepack	ANDA	Current
72189-058	ALPRAZOLAM	ALPRAZOLAM	DIRECT RX	ANDA	Current
75921-901	ALPRAZOLAM	Alprazolam	Life Line Home Care Services, Inc.	ANDA	Current