Application 074314

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALPRAZOLAM	ALPRAZOLAM	SOLUTION;ORAL	0.5MG/5ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074314-001	ALPRAZOLAM	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL			1993-10-31

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 2 · 43 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	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074314-001	ALPRAZOLAM	0.5MG/5ML	SOLUTION / ORAL	1993-10-31	`f41ea6bd6efb…`

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 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	REMEDYREPACK INC.	563e09db-2f3d-4ce8-b356-ae44477be6d0	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Clinical Solutions Wholesale, LLC	0cf8b567-201b-44fa-8fd3-c74023aff44f	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	4203d3fe-916e-41af-9daf-f58f4fed6f9c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	St. Mary's Medical Park Pharmacy	fc5fe795-6b41-aecf-e053-6394a90af562	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	68d8b8d1-00a4-42c4-a796-90211fee1a6d	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	aaab422d-c763-4352-8ffc-5aafdf91e8dd	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	0dce8232-0b0e-4f81-af95-36e6febdb550	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Coupler LLC	5111e57d-8920-6861-e063-6294a90a2194	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	ASCLEMED USA INC.	8d76a554-7ed1-4c93-a5ea-30898aec0aa1	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Coupler LLC	509a8a86-d61c-3f05-e063-6394a90a52ca	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Par Health USA, LLC	ff1630b4-2044-433c-96bc-0bb4ae8d42a0	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	2bd0d4c6-0fde-46f2-bb13-da25d50427df	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	d8364af1-d23e-4cd7-9a81-077ae97a951a	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	0e2644fa-8334-4209-a63d-2466b5ab55b4	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Proficient Rx LP	c6795ed8-af28-41f4-b85b-48e1fe9d0369	2026-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	PreferredPharmaceuticals Inc.	dc130aae-4510-4de7-a750-4a144e88208d	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Preferred Pharmaceuticals Inc.	73c1d1dc-ade2-4bb4-b109-83bd63acd15c	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Preferred Pharmaceuticals Inc.	78682252-e448-4b20-b49d-27c2c70e4cb3	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	A-S Medication Solutions	8ef75d22-4a7c-48d5-a532-5a43b8593e7c	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Natco Pharma USA LLC	b3c55877-2538-4892-bdb1-d618c643d29c	2026-01-13	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22333	ORIG	2005-07-22