FDA.reportPublic FDA data

Application 204792

Type
ANDA
Sponsor
HETERO LABS LTD V

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
A204792-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2024-01-09
A204792-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2024-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204792-001AB
A204792-002AB

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 22:54:322026-06A204792-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2024-01-09a50c72e98297…
2026-08-01 22:54:322026-06A204792-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2024-01-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204792-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204792-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FESOTERODINE FUMARATEFESOTERODINE FUMARATENorthStar RxLLCcb597206-1c75-4a4f-a17a-524a2010a4b92025-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204792
application number: ANDA204792
FESOTERODINE FUMARATEFESOTERODINE FUMARATECamber Pharmaceuticals, Inc.dc532c6c-ff0d-488a-8a92-b1b0f37c944e2025-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204792
application number: ANDA204792