Application 074199

Type: ANDA
Sponsor: ROXANE

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A074199-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19
A074199-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19
A074199-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074199-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1993-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074199-003	ALPRAZOLAM	1MG	TABLET / ORAL	1993-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074199-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1993-10-19	`301d65b070ca…`

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 3 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	f7e63d96-2310-4ab1-e053-6294a90a86fc	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	aaf7979c-168a-0da2-e053-2995a90a4d12	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	b43df4ca-8d28-7b3a-e053-2a95a90aa4d7	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Advanced Rx Pharmacy of Tennessee, LLC	b39e2bc8-b691-0f4e-e053-2995a90a00fd	2024-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Sandoz Inc	d9b0e228-17cf-40d7-b62e-5050311c571c	2024-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	8ca8e0fc-6c3d-48d4-ad04-708182b45350	2024-05-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam Extended Release	ALPRAZOLAM	Bryant Ranch Prepack	29477df1-68aa-44b3-bf9e-80ecff6ce879	2024-05-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALPRAZOLAM
Xanax	ALPRAZOLAM	Viatris Specialty LLC	bb5cf72e-3a41-41a8-9a38-80f974eca33f	2024-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	25781f50-d309-4c4f-9e21-c019e068d101	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	b0000772-2514-45a2-a75d-1bbb13c29989	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Medsource Pharmaceuticals	14960c0c-555f-acc1-e063-6394a90a232a	2024-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Amneal Pharmaceuticals LLC	259387c1-e374-4bc2-9510-5f7f2c60d1a5	2024-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	f9903822-642d-e364-e053-6394a90a22d8	2024-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Asclemed USA, Inc.	e3245259-024f-4bd9-9ec6-94aa11febfd7	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Asclemed USA, Inc.	5d839a8b-0f45-42bf-acc1-2bd28f948e53	2024-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Proficient Rx LP	60c90b4b-174f-4fd2-b65f-fc166c16bdc1	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Proficient Rx LP	68e6ef8c-4104-4636-9719-6aa386c892d9	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	f95f4030-e8e0-416f-951d-c4dac09f386a	2023-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Proficient Rx LP	10de2b3b-3b3f-4a5a-a9e7-a8401f53b8cc	2023-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	ANI Pharmaceuticals, Inc.	38428a1b-718c-49cc-94ae-2e3644ba6256	2023-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.