Application 074224

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIAZOLAM	TRIAZOLAM	TABLET;ORAL	0.125MG	No	No
002	TRIAZOLAM	TRIAZOLAM	TABLET;ORAL	0.25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074224-001	TRIAZOLAM	TRIAZOLAM	0.125MG	TABLET / ORAL			1994-06-01
A074224-002	TRIAZOLAM	TRIAZOLAM	0.25MG	TABLET / ORAL			1994-06-01

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL		1994-06-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL		1994-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	1994-06-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	1994-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	1994-06-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	1994-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	1994-06-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	1994-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	1994-06-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	1994-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074224-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	1994-06-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074224-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	1994-06-01	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074224-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074224-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074224-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074224-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074224-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074224-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074224-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074224-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074224-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074224-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074224-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074224-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074224-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074224-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074224-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074224-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074224-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074224-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074224-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074224-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074224-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074224-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074224-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074224-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074224-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074224-002	AB	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A074224-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074224-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074224-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074224-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074224-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074224-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074224-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074224-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074224-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074224-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074224-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074224-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074224-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074224-002	AB	1	`053a50430f4f…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triazolam	TRIAZOLAM	Mylan Pharmaceuticals Inc.	5add318e-11b9-42f8-b052-0d8cebb32fcf	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triazolam generic name: TRIAZOLAM
Triazolam	TRIAZOLAM	Proficient Rx LP	ba1d8955-41f8-4b4d-8ed8-e92667e294a1	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triazolam generic name: TRIAZOLAM
Triazolam	TRIAZOLAM	A-S Medication Solutions	0a96c618-1869-4cb6-b9f3-549e8581af72	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triazolam generic name: TRIAZOLAM
Triazolam	TRIAZOLAM	PD-Rx Pharmaceuticals, Inc.	f8ca4773-e201-4cb9-8869-5ee07ba1d0bf	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triazolam generic name: TRIAZOLAM
Triazolam	TRIAZOLAM	Bryant Ranch Prepack	5fccc31d-32c9-49e7-91a9-664cc726872b	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triazolam generic name: TRIAZOLAM
Triazolam	TRIAZOLAM	Zydus Lifesciences Limited	4084da13-5825-4399-ad69-de701508c71d	2024-08-14		Name fallback brand name: Triazolam generic name: TRIAZOLAM
Triazolam	TRIAZOLAM	A-S Medication Solutions	5a330f08-5d8f-4f8d-8847-a45b734412b4	2023-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triazolam generic name: TRIAZOLAM
Triazolam	TRIAZOLAM	Zydus Pharmaceuticals USA Inc.	8d414eb8-eec9-486f-90fc-00eed0cf7daf	2023-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triazolam generic name: TRIAZOLAM
Triazolam	TRIAZOLAM	Ingenus Pharmaceuticals, LLC	a0c99f0b-4122-4611-9b53-80fadfceacb6	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triazolam generic name: TRIAZOLAM
Triazolam	TRIAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	97164a9c-4bc7-4f15-829e-5f9e653c7fa5	2017-11-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Triazolam generic name: TRIAZOLAM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-4858	Triazolam	Triazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-4858	Triazolam	Triazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-4858	Triazolam	Triazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-4858	Triazolam	Triazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-4858	Triazolam	Triazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-4859	Triazolam	Triazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-4859	Triazolam	Triazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-4859	Triazolam	Triazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-4859	Triazolam	Triazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-4859	Triazolam	Triazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
21695-284	Triazolam	Triazolam	Rebel Distributors Corp	ANDA	Current
21695-303	Triazolam	Triazolam	Rebel Distributors Corp	ANDA	Current
43063-996	Triazolam	Triazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-996	Triazolam	Triazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-996	Triazolam	Triazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-996	Triazolam	Triazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-996	Triazolam	Triazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-996	Triazolam	Triazolam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-4733	Triazolam	Triazolam	A-S Medication Solutions	ANDA	Current
50090-4733	Triazolam	Triazolam	A-S Medication Solutions	ANDA	Current
63629-2956	Triazolam	Triazolam	Bryant Ranch Prepack	ANDA	Current
63629-2956	Triazolam	Triazolam	Bryant Ranch Prepack	ANDA	Current
67544-725	Triazolam	Triazolam	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current