Application 204868

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	4MG	No	No
002	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	8MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204868-001	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL			2023-01-04
A204868-002	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL			2023-01-04

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 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2023-01-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204868-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204868-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`a67488948f0b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204868-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204868-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204868-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204868-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204868-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204868-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204868-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204868-002	AB	1	`3bdfa0b2c4d7…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fesoterodine Fumarate	FESOTERODINE FUMARATE	Ascend Laboratories, LLC	b1abd9cb-c480-437b-8531-e2de3e188363	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Fesoterodine Fumarate generic name: FESOTERODINE FUMARATE
Toviaz	FESOTERODINE FUMARATE	Pfizer Laboratories Div Pfizer Inc	5be745f0-8ae7-4c3c-9962-37d6263326f1	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: FESOTERODINE FUMARATE
Fesoterodine fumarate	FESOTERODINE FUMARATE	Golden State Medical Supply, Inc.	e5e6e146-d39a-471c-e053-2995a90a7538	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Fesoterodine fumarate generic name: FESOTERODINE FUMARATE
Fesoterodine fumarate	FESOTERODINE FUMARATE	Dr.Reddy's Laboratories Inc.,	5c5d2a97-9029-744f-c410-a4bbbe9761a8	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: Fesoterodine fumarate generic name: FESOTERODINE FUMARATE
Fesoterodine Fumarate	FESOTERODINE FUMARATE	Alembic Pharmaceuticals Inc.	299db62d-9658-4796-b449-657fa859c5cd	2025-06-17	Warnings, Adverse reactions	Name fallback brand name: Fesoterodine Fumarate generic name: FESOTERODINE FUMARATE
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	NorthStar RxLLC	cb597206-1c75-4a4f-a17a-524a2010a4b9	2025-03-05	Warnings, Adverse reactions	Name fallback brand name: FESOTERODINE FUMARATE generic name: FESOTERODINE FUMARATE
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	Camber Pharmaceuticals, Inc.	dc532c6c-ff0d-488a-8a92-b1b0f37c944e	2025-03-04	Warnings, Adverse reactions	Name fallback brand name: FESOTERODINE FUMARATE generic name: FESOTERODINE FUMARATE
fesoterodine fumarate	FESOTERODINE FUMARATE	Zydus Pharmaceuticals USA Inc.	8c68e918-b47b-466d-80bc-4f521aa74607	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: fesoterodine fumarate generic name: FESOTERODINE FUMARATE
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	Aurobindo Pharma Limited	dc8f6158-3c2b-4ec0-a951-e04468b83bb1	2024-12-02	Warnings, Adverse reactions	Name fallback brand name: FESOTERODINE FUMARATE generic name: FESOTERODINE FUMARATE
fesoterodine fumarate	FESOTERODINE FUMARATE	Zydus Lifesciences Limited	26e8cc63-1e1d-4a77-8f53-4c38bcf0d443	2024-11-30		Name fallback brand name: fesoterodine fumarate generic name: FESOTERODINE FUMARATE
Fesoterodine Fumarate	FESOTERODINE FUMARATE	Amneal Pharmaceuticals LLC	1d3fdfcf-7406-4be0-90e9-b10c9257bf69	2024-04-12	Warnings, Adverse reactions	Name fallback brand name: Fesoterodine Fumarate generic name: FESOTERODINE FUMARATE
Fesoterodine Fumarate	FESOTERODINE FUMARATE	Alembic Pharmaceuticals Limited	571147f2-e182-44b5-9d0b-ecfc3265cc2d	2023-01-30	Warnings, Adverse reactions	Name fallback brand name: Fesoterodine Fumarate generic name: FESOTERODINE FUMARATE