Application 021412

Type: NDA
Sponsor: BIOVAIL LABS INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOVALT ODT	ZOLPIDEM TARTRATE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	No	No
002	TOVALT ODT	ZOLPIDEM TARTRATE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No

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

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
N021412-001	TOVALT ODT	ZOLPIDEM TARTRATE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2007-04-25
N021412-002	TOVALT ODT	ZOLPIDEM TARTRATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2007-04-25

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021412-001	TOVALT ODT	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021412-002	TOVALT ODT	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021412-001	TOVALT ODT	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021412-002	TOVALT ODT	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021412-001	TOVALT ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-04-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021412-002	TOVALT ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-04-25	`74a2ff9319b5…`

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 2 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Direct_Rx	907c7b18-2638-512c-e053-2995a90ae6fd	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Northwind Health Company, LLC	47212207-52a1-938b-e063-6294a90abca8	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Northwind Health Company, LLC	26e20f53-c042-eac0-e063-6394a90acfca	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Lupin Pharmaceuticals, Inc.	ac647afe-2fe5-4056-806f-abdd54789b45	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	91511d2f-7066-49a0-90ea-2940d955c85e	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	ef72eb73-d058-4ca3-9013-691aae8426fb	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
zolpidem tartrate	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	41124767-8ff7-da5d-e063-6394a90a5203	2025-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	8425be72-2bbe-4090-b00e-610f1a1646b1	2025-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Cardinal Health 107, LLC	83510333-f07d-4b81-a3ae-2801d114bd31	2025-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
zolpidem tartrate	ZOLPIDEM TARTRATE	Almatica Pharma LLC	2f1a3600-9bd6-3651-3ab5-1e4e0b0a3916	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals, Inc.	a9ac3d4e-f502-41e3-95c0-0d334584566d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals Inc.	76ff87e4-3aa2-439d-8436-d9e6affb33c8	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals, Inc..	72e19b8e-d13a-4824-aee4-11778eba552c	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals Inc.	625fad5b-8817-4773-a2fc-20b662140e6e	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	028bf425-7a72-464d-a242-aa5deee1ac23	2025-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	ST. MARY'S MEDICAL PARK PHARMACY	3bc8a122-aa21-212c-e063-6394a90a3bda	2025-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	9922ce14-b418-4235-9c59-d674a8e70210	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	3882d72d-686b-406b-e063-6294a90a0b89	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	a1faca42-6e46-4586-97ac-050b724e7d2a	2025-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	92c58053-7ed8-4a3d-a2f7-8e30c4e5a367	2025-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE

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
42143	ORIG	2009-04-14
36861	ORIG	2007-05-01
5305	ORIG	2007-05-01
27718	ORIG	2005-05-27