Application 017661

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAVIST	CLEMASTINE FUMARATE	TABLET;ORAL	2.68MG	Yes	No
002	TAVIST-1	CLEMASTINE FUMARATE	TABLET;ORAL	1.34MG	No	No
003	TAVIST-1	CLEMASTINE FUMARATE	TABLET;ORAL	1.34MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N017661-001	TAVIST	CLEMASTINE FUMARATE	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N017661-002	TAVIST-1	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL	Approved before 1982
N017661-003	TAVIST-1	CLEMASTINE FUMARATE	1.34MG	TABLET / ORAL		1992-08-21

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 4 · 129 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	N017661-001	TAVIST	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017661-001	TAVIST	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017661-001	TAVIST	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017661-001	TAVIST	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017661-001	TAVIST	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017661-001	TAVIST	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017661-001	TAVIST	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017661-001	TAVIST	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017661-001	TAVIST	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017661-001	TAVIST	2.68MG	TABLET / ORAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017661-001	TAVIST	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017661-001	TAVIST	2.68MG	TABLET / ORAL	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017661-001	TAVIST	2.68MG	TABLET / ORAL	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017661-002	TAVIST-1	1.34MG	TABLET / ORAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017661-003	TAVIST-1	1.34MG	TABLET / ORAL		1992-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017661-001	TAVIST	2.68MG	TABLET / ORAL	RLD, Approved before 1982		`301d65b070ca…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLEMSZA	CLEMASTINE FUMARATE	IPG Pharmaceuticals, Inc.	9a35ed77-e35c-4c54-ad7f-1b92e450fa20	2025-07-30	Warnings, Adverse reactions	Name fallback generic name: CLEMASTINE FUMARATE
Clemastine Fumarate	CLEMASTINE FUMARATE	Genus Lifesciences	cf8a3449-8bb3-4d5c-8d0d-557590e49ee5	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: CLEMASTINE FUMARATE
Clemastine Fumarate	CLEMASTINE FUMARATE	Genus Lifesciences	5c99e7af-86a5-4c17-82d5-2d4119e4fe72	2024-11-25	Warnings, Adverse reactions	Name fallback generic name: CLEMASTINE FUMARATE
CLEMASTINE FUMARATE	CLEMASTINE FUMARATE	Chartwell RX, LLC	6663f1b0-5353-401f-b9d3-d9f69ad08fbf	2023-07-07	Warnings, Adverse reactions	Name fallback generic name: CLEMASTINE FUMARATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.