Application 017892

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALCION	TRIAZOLAM	TABLET;ORAL	0.25MG	Yes	Yes
002	HALCION	TRIAZOLAM	TABLET;ORAL	0.5MG	No	No
003	HALCION	TRIAZOLAM	TABLET;ORAL	0.125MG	Yes	No

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

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	TE codes	RLD / RS	Approval date
N017892-001	HALCION	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15
N017892-002	HALCION	TRIAZOLAM	0.5MG	TABLET / ORAL			1982-11-15
N017892-003	HALCION	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N017892-001	AB
N017892-003	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017892-002	HALCION	0.5MG	TABLET / ORAL			1982-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017892-003	HALCION	0.125MG	TABLET / ORAL	AB	RLD	1985-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017892-001	HALCION	0.25MG	TABLET / ORAL	AB	RLD, RS	1982-11-15	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N017892-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017892-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017892-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017892-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017892-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017892-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017892-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017892-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017892-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017892-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017892-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017892-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017892-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017892-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017892-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017892-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017892-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017892-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017892-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017892-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017892-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017892-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017892-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017892-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017892-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017892-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017892-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017892-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017892-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017892-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017892-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017892-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017892-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017892-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017892-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017892-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017892-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017892-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017892-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017892-003	AB	1	`bb7c543d1eb4…`

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 · 2 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	Exact identifier application applno (NDA): 017892 application number: NDA017892 ndc (product): 59762-3717 ndc (product): 59762-3718
Triazolam	TRIAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	97164a9c-4bc7-4f15-829e-5f9e653c7fa5	2017-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017892 application number: NDA017892 ndc (product): 43353-451

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0017	Halcion	triazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0017	Halcion	triazolam	Pharmacia and Upjohn Comp	NDA	Current
0009-0017	Halcion	triazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0017	Halcion	triazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0017	Halcion	triazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0017	Halcion	triazolam	Pharmacia & Upjohn Company LLC	NDA	Current
43353-451	Triazolam	triazolam	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
50090-0522	Triazolam	triazolam	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-0522	Triazolam	triazolam	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50436-3718	Triazolam	triazolam	Unit Dose Services	NDA AUTHORIZED GENERIC	Current
55289-787	Triazolam	triazolam	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-787	Triazolam	triazolam	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-787	Triazolam	triazolam	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-787	Triazolam	triazolam	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-787	Triazolam	triazolam	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
59762-3717	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED	Current
59762-3717	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3717	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3717	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3717	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3717	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3718	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED	Current
59762-3718	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3718	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3718	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3718	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3718	Triazolam	triazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73197	SUPPL	2023-01-17
73196	SUPPL	2023-01-17
73169	SUPPL	2023-01-17
69170	SUPPL	2021-10-29
69146	SUPPL	2021-10-29
69148	SUPPL	2021-10-28
66186	SUPPL	2021-02-11
66185	SUPPL	2021-02-11
66128	SUPPL	2021-02-09
60532	SUPPL	2019-10-10
60531	SUPPL	2019-10-10
60511	SUPPL	2019-10-10
57595	SUPPL	2019-02-14
57474	SUPPL	2019-02-07
46463	SUPPL	2016-12-22
46315	SUPPL	2016-12-20
13946	SUPPL	2014-09-23
33365	SUPPL	2014-09-22
11088	SUPPL	2008-02-14
740	SUPPL	2008-02-14
23538	ORIG	2007-03-16
20096	SUPPL	2006-05-08
13945	SUPPL	2003-07-06