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N021412-001	TOVALT ODT	ZOLPIDEM TARTRATE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2007-04-25
N021412-002	TOVALT ODT	ZOLPIDEM TARTRATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2007-04-25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N021412-001	TOVALT ODT	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`84e616aacf4f…`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N021412-002	TOVALT ODT	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`84e616aacf4f…`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N021412-001	TOVALT ODT	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`caaa826d4ba7…`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 6 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	Proficient Rx LP	acf9f431-3013-4cfd-ba4d-c4013f20bdab	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	8581cfad-525b-4b16-b116-a5138d9fda52	2022-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	35f6c1ab-a61c-4625-b932-11a7483f1d84	2022-10-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Edluar	ZOLPIDEM TARTRATE	Viatris Specialty LLC	a32884d0-85b5-11de-8a39-0800200c9a66	2022-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Proficient Rx LP	f76eb9d8-ca7d-4479-bd16-52a57f623b02	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Proficient Rx LP	eaca34da-2b12-4dd4-91b5-a8446c7bd41e	2022-07-01	Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Proficient Rx LP	e1f43bde-efba-42be-adef-94e1ef6664fd	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	25e71199-c55d-4cc6-8388-b309d654d2b0	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Lupin Pharmaceuticals,Inc.	6db679f6-b1f8-4fbf-9e87-9cef4650c45a	2020-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	facfc337-3447-4052-a9aa-8aa55282a3e3	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	e534b3ac-1110-465f-8692-6ea585996fb6	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	e8572fd4-70c7-4c94-a0d7-9b4be6fa8f77	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	ebd6c66b-b230-48d7-b38f-d610b6cb2b6c	2019-03-02	Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	acfcfe91-83a0-44ab-95c0-dd98b73ac69a	2019-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7be7f243-e6f8-406f-aed7-be7cedd5630a	2018-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	7abb6898-223c-487b-856c-068ac04f7a5c	2018-09-25	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