Application 204973

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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 42.

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
A204973-001	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-01-04
A204973-002	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-01-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204973-001	AB
A204973-002	AB

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 · 50 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
2026-08-18 06:07:40	2026-07	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204973-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204973-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204973-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204973-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204973-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204973-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204973-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204973-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204973-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204973-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204973-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204973-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204973-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204973-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204973-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204973-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204973-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204973-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204973-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204973-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204973-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204973-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204973-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204973-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204973-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204973-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204973-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204973-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204973-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204973-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204973-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204973-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204973-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204973-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204973-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204973-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204973-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204973-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204973-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204973-002	AB	1	`9b2671bbb829…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fesoterodine Fumarate	FESOTERODINE FUMARATE	Alembic Pharmaceuticals Inc.	299db62d-9658-4796-b449-657fa859c5cd	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204973 application number: ANDA204973 ndc (product): 62332-175 ndc (product): 62332-176
Fesoterodine Fumarate	FESOTERODINE FUMARATE	Alembic Pharmaceuticals Limited	571147f2-e182-44b5-9d0b-ecfc3265cc2d	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204973 application number: ANDA204973

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62332-175	Fesoterodine Fumarate	Fesoterodine Fumarate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-176	Fesoterodine Fumarate	Fesoterodine Fumarate	Alembic Pharmaceuticals Inc.	ANDA	Current