FDA.reportPublic FDA data

Application 204504

Type
ANDA
Sponsor
AMERIGEN PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FESOTERODINE FUMARATEFESOTERODINE FUMARATETABLET, EXTENDED RELEASE;ORAL4MGNoNo
002FESOTERODINE FUMARATEFESOTERODINE FUMARATETABLET, EXTENDED RELEASE;ORAL8MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204504-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORAL2023-01-04
A204504-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORAL2023-01-04

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204504-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORAL2023-01-04a50c72e98297…
2026-08-01 22:54:322026-06A204504-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORAL2023-01-04a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fesoterodine FumarateFESOTERODINE FUMARATEAscend Laboratories, LLCb1abd9cb-c480-437b-8531-e2de3e1883632026-07-16Warnings, Adverse reactionsName fallback
brand name: Fesoterodine Fumarate
generic name: FESOTERODINE FUMARATE
ToviazFESOTERODINE FUMARATEPfizer Laboratories Div Pfizer Inc5be745f0-8ae7-4c3c-9962-37d6263326f12026-04-07Warnings, Adverse reactionsName fallback
generic name: FESOTERODINE FUMARATE
Fesoterodine fumarateFESOTERODINE FUMARATEGolden State Medical Supply, Inc.e5e6e146-d39a-471c-e053-2995a90a75382025-12-18Warnings, Adverse reactionsName fallback
brand name: Fesoterodine fumarate
generic name: FESOTERODINE FUMARATE
Fesoterodine fumarateFESOTERODINE FUMARATEDr.Reddy's Laboratories Inc.,5c5d2a97-9029-744f-c410-a4bbbe9761a82025-09-01Warnings, Adverse reactionsName fallback
brand name: Fesoterodine fumarate
generic name: FESOTERODINE FUMARATE
Fesoterodine FumarateFESOTERODINE FUMARATEAlembic Pharmaceuticals Inc.299db62d-9658-4796-b449-657fa859c5cd2025-06-17Warnings, Adverse reactionsName fallback
brand name: Fesoterodine Fumarate
generic name: FESOTERODINE FUMARATE
FESOTERODINE FUMARATEFESOTERODINE FUMARATENorthStar RxLLCcb597206-1c75-4a4f-a17a-524a2010a4b92025-03-05Warnings, Adverse reactionsName fallback
brand name: FESOTERODINE FUMARATE
generic name: FESOTERODINE FUMARATE
FESOTERODINE FUMARATEFESOTERODINE FUMARATECamber Pharmaceuticals, Inc.dc532c6c-ff0d-488a-8a92-b1b0f37c944e2025-03-04Warnings, Adverse reactionsName fallback
brand name: FESOTERODINE FUMARATE
generic name: FESOTERODINE FUMARATE
fesoterodine fumarateFESOTERODINE FUMARATEZydus Pharmaceuticals USA Inc.8c68e918-b47b-466d-80bc-4f521aa746072025-01-01Warnings, Adverse reactionsName fallback
brand name: fesoterodine fumarate
generic name: FESOTERODINE FUMARATE
FESOTERODINE FUMARATEFESOTERODINE FUMARATEAurobindo Pharma Limiteddc8f6158-3c2b-4ec0-a951-e04468b83bb12024-12-02Warnings, Adverse reactionsName fallback
brand name: FESOTERODINE FUMARATE
generic name: FESOTERODINE FUMARATE
fesoterodine fumarateFESOTERODINE FUMARATEZydus Lifesciences Limited26e8cc63-1e1d-4a77-8f53-4c38bcf0d4432024-11-30Name fallback
brand name: fesoterodine fumarate
generic name: FESOTERODINE FUMARATE
Fesoterodine FumarateFESOTERODINE FUMARATEAmneal Pharmaceuticals LLC1d3fdfcf-7406-4be0-90e9-b10c9257bf692024-04-12Warnings, Adverse reactionsName fallback
brand name: Fesoterodine Fumarate
generic name: FESOTERODINE FUMARATE
Fesoterodine FumarateFESOTERODINE FUMARATEAlembic Pharmaceuticals Limited571147f2-e182-44b5-9d0b-ecfc3265cc2d2023-01-30Warnings, Adverse reactionsName fallback
brand name: Fesoterodine Fumarate
generic name: FESOTERODINE FUMARATE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62559-376Fesoterodine FumarateFesoterodine FumarateANI Pharmaceuticals, Inc.ANDACurrent