Application 021434

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XANAX XR	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	0.5MG	Yes	No
002	XANAX XR	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	1MG	Yes	No
003	XANAX XR	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	2MG	Yes	No
004	XANAX XR	ALPRAZOLAM	TABLET, EXTENDED RELEASE;ORAL	3MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	RLD / RS	Approval date
N021434-001	XANAX XR	ALPRAZOLAM	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17
N021434-002	XANAX XR	ALPRAZOLAM	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17
N021434-003	XANAX XR	ALPRAZOLAM	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17
N021434-004	XANAX XR	ALPRAZOLAM	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021434-001	AB
N021434-002	AB
N021434-003	AB
N021434-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021434-001	XANAX XR	0.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-002	XANAX XR	1MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-003	XANAX XR	2MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-004	XANAX XR	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-01-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021434-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021434-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021434-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021434-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021434-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021434-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021434-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021434-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021434-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021434-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021434-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021434-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021434-004	AB	1	`d06236e962d9…`

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
Alprazolam XR	ALPRAZOLAM	Mylan Pharmaceuticals Inc.	1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021434 application number: NDA021434 ndc (product): 59762-0068 ndc (product): 59762-0057 ndc (product): 59762-0066 ndc (product): 59762-0059
Xanax XR	ALPRAZOLAM	Viatris Specialty LLC	c8990714-c2f5-4b0c-9f1c-91d77156d962	2023-04-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021434 application number: NDA021434

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0057	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0057	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0057	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0057	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0057	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0057	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0059	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0059	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0059	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0059	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0059	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0059	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0066	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0066	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0066	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0066	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0066	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0066	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0068	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0068	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0068	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0068	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0068	Xanax	alprazolam	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0068	Xanax	alprazolam	Pharmacia & Upjohn Company LLC	NDA	Current
35356-503	Alprazolam	alprazolam	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
35356-504	Alprazolam	alprazolam	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
59762-0057	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0057	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0057	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0057	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0057	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0059	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0059	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0059	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0059	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0059	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0066	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0066	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0066	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0066	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0066	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0068	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0068	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0068	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0068	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0068	Alprazolam	alprazolam	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73418	SUPPL	2023-02-08
73362	SUPPL	2023-02-02
73356	SUPPL	2023-02-01
73237	SUPPL	2023-01-17
66454	SUPPL	2021-03-02
66449	SUPPL	2021-03-02
66192	SUPPL	2021-02-11
66191	SUPPL	2021-02-11
66132	SUPPL	2021-02-09
46633	SUPPL	2016-12-30
46466	SUPPL	2016-12-22
46242	SUPPL	2016-12-20
5359	SUPPL	2011-08-26
15453	SUPPL	2011-08-24
15452	SUPPL	2011-06-07
5358	SUPPL	2011-06-03
42157	SUPPL	2006-10-25
42156	ORIG	2004-12-07
27760	ORIG	2004-06-30
27761	SUPPL	2004-04-07
36912	ORIG	2003-03-06