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N021412-001	TOVALT ODT	ZOLPIDEM TARTRATE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2007-04-25
N021412-002	TOVALT ODT	ZOLPIDEM TARTRATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2007-04-25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N021412-001	TOVALT ODT	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`84e616aacf4f…`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N021412-002	TOVALT ODT	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`84e616aacf4f…`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N021412-001	TOVALT ODT	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-04-25	`caaa826d4ba7…`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 3 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	Aphena Pharma Solutions - Tennessee, LLC	349053e4-9885-ec0b-e063-6294a90ad79a	2025-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1e15d6e3-8d06-0936-e063-6394a90ab8db	2025-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	3310d63e-d79a-175d-e063-6394a90a4270	2025-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Ambien	ZOLPIDEM TARTRATE	Sanofi-Aventis U.S. LLC	c36cadf4-65a4-4466-b409-c82020b42452	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	30c057fb-2e1b-4b9c-8c8a-79c322151e61	2025-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals Inc.	d579c6ca-c820-49ff-92fb-2e6aaad3b052	2025-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	e5e2d31b-ce26-78b0-e053-2a95a90ac491	2025-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Ambien	ZOLPIDEM TARTRATE	Cosette Pharmaceuticals, Inc.	747949c5-2c91-4909-8a07-71b6826f8e97	2025-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Ambien CR	ZOLPIDEM TARTRATE	Cosette Pharmaceuticals, Inc.	2d934da3-bd77-4470-e063-6294a90a64f5	2025-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	38c838a4-9943-445a-8e80-e823d56eeaa5	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	fda413e7-b1ae-312a-e053-6394a90ab2c6	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	DIRECT RX	c3f23bc3-595b-28e5-e053-2a95a90a9c2c	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals, Inc.	2b9f696a-b637-4dea-e063-6394a90aeb2e	2025-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87ae17-a3c5-a3a5-e053-2a95a90aa4b0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87b722-cdb7-0b17-e053-2a95a90a315b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87df4e-2c97-e23e-e053-2a95a90ab354	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	b2db3979-daa6-6e83-e053-2a95a90a3a2f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	c8adec28-9dcd-4a7e-e053-2a95a90a991e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	c859c752-8a85-2017-e053-2a95a90a771f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	fc76ab4c-3607-39c3-e053-6394a90a6877	2024-12-31	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