Application 074215

Type: ANDA
Sponsor: MYLAN

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 43.

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	Approval date
A074215-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27
A074215-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27
A074215-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27
A074215-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27

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 · 172 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	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074215-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074215-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074215-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074215-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074215-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074215-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074215-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074215-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074215-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074215-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074215-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074215-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074215-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074215-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074215-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074215-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074215-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074215-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074215-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074215-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074215-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074215-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074215-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074215-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074215-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074215-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074215-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074215-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074215-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074215-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074215-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074215-004	AB	1	`ea99ee380514…`

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 4 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	54c790c5-2e6c-439d-8e3b-7502c962a596	2023-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Hikma Pharmaceuticals USA Inc.	b945ac6f-796e-41ef-85e9-61007e4a4e9a	2023-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Xanax	ALPRAZOLAM	PHARMACIA & UPJOHN COMPANY LLC	388e249d-b9b6-44c3-9f8f-880eced0239f	2023-01-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Actavis Pharma, Inc.	a23063c0-099a-4256-b95f-3a857bbf704b	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Actavis Pharma, Inc.	5ceed721-2e65-4c81-bd84-f110b1ac9d2e	2022-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Proficient Rx LP	4579facb-b225-4108-a5ef-dada926ef7cf	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Proficient Rx LP	34631dbf-f817-484d-8bcf-f8efa07178d7	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Proficient Rx LP	969acb29-3b5c-47ed-8f7d-a960a24e72e3	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Proficient Rx LP	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	2020-08-01	Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Proficient Rx LP	447efe78-3696-481c-bbae-23199a39ec94	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Proficient Rx LP	f6990b57-7011-4cdf-8abc-1794e2e0c7f1	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	29ddd9f2-c116-467b-8db3-38166482aea0	2018-08-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	2717699a-c8b6-4590-937a-cb86eadc5296	2018-08-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alprazolam generic name: ALPRAZOLAM
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	964d7f43-34a6-45af-a95f-3b9ade17c6a5	2018-02-05	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4001	Alprazolam	alprazolam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4001	Alprazolam	alprazolam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4003	Alprazolam	alprazolam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4003	Alprazolam	alprazolam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4005	Alprazolam	alprazolam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4005	Alprazolam	alprazolam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4007	Alprazolam	alprazolam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4007	Alprazolam	alprazolam	Mylan Pharmaceuticals Inc.	ANDA	Current
12634-525	Alprazolam	Alprazolam	Apotheca, Inc	ANDA	Current
51079-788	Alprazolam	alprazolam	Mylan Institutional Inc.	ANDA	Current
51079-789	Alprazolam	alprazolam	Mylan Institutional Inc.	ANDA	Current
51079-790	Alprazolam	alprazolam	Mylan Institutional Inc.	ANDA	Current
55154-4398	Alprazolam	alprazolam	Cardinal Health	ANDA	Current
55154-5451	Alprazolam	Alprazolam	Cardinal Health	ANDA	Current
55154-5499	Alprazolam	Alprazolam	Cardinal Health	ANDA	Current
55154-5553	Alprazolam	Alprazolam	Cardinal Health	ANDA	Current
55289-920	Alprazolam	alprazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55700-422	Alprazolam	alprazolam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-602	Alprazolam	alprazolam	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63187-278	Alprazolam	alprazolam	Proficient Rx LP	ANDA	Current
63187-278	Alprazolam	alprazolam	Proficient Rx LP	ANDA	Current
67296-1303	Alprazolam	Alprazolam	RedPharm Drug, Inc.	ANDA	Current
67296-1303	Alprazolam	Alprazolam	RedPharm Drug, Inc.	ANDA	Current
67296-1313	Alprazolam	Alprazolam	RedPharm Drug, Inc.	ANDA	Current
67296-1313	Alprazolam	Alprazolam	RedPharm Drug, Inc.	ANDA	Current
67544-006	Alprazolam	alprazolam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-007	Alprazolam	alprazolam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-124	Alprazolam	alprazolam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current