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N021412-001	TOVALT ODT	ZOLPIDEM TARTRATE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2007-04-25
N021412-002	TOVALT ODT	ZOLPIDEM TARTRATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2007-04-25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N021412-001	TOVALT ODT	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`84e616aacf4f…`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N021412-002	TOVALT ODT	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`84e616aacf4f…`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N021412-001	TOVALT ODT	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`caaa826d4ba7…`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 4 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	Advanced Rx Pharmacy of Tennessee, LLC	f939549f-14a6-d37c-e053-6294a90a034a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Lake Erie Medical DBA Quality Care Products LLC	db735db9-1c82-4d32-bf91-97b05a75e876	2024-12-17	Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	3ba3c29f-3835-4f4f-a39f-56fb42686f5b	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	82bca7a0-021f-4e35-8b3f-6390eeb863a6	2024-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	95b0ba48-4e71-25f7-e053-2a95a90aea82	2024-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1e13ad50-f846-813a-e063-6294a90a5878	2024-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Sandoz Inc	0553e26c-f2aa-43aa-adf9-6eb951a501d3	2024-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	ce301d8b-0a8c-4404-8697-57222ae17a44	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	8cef5718-c562-43c3-8abe-a2fc5235ad2a	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	fff2e7fc-2f7e-43c9-bfb3-d929ecc9eb72	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	American Health Packaging	eb850154-4b4b-4d9a-8476-aea1a93fe8d7	2024-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Chartwell RX, LLC	0dd113e1-f789-48d2-8cb2-d39b71273658	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	3bbc3c35-2811-4a67-9dcc-5eed38ef8b52	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	f9c108d1-5e2f-41c7-a845-2aed48c30905	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	604e77ef-2cda-4efc-abfb-9af549d40fd4	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	74c4e793-3444-4d3d-8211-26374349ab1e	2024-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	1fa86b79-8809-35f4-e063-6394a90a4377	2024-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	1a8f7696-0d02-dd1f-e063-6394a90a5866	2024-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	ac8c412a-0f94-7c3a-e053-2995a90afdc7	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals, Inc	4be6ce23-e7b1-510e-e054-00144ff8d46c	2024-07-16	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