FDA.reportPublic FDA data

Application 204975

Type
ANDA
Sponsor
DR REDDYS LABS 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
A204975-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2019-08-13
A204975-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2019-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204975-001AB
A204975-002AB

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 22:54:322026-06A204975-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2019-08-13a50c72e98297…
2026-08-01 22:54:322026-06A204975-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2019-08-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204975-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204975-002AB1a50c72e98297…

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 FUMARATEGolden State Medical Supply, Inc.e5e6e146-d39a-471c-e053-2995a90a75382025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204975
application number: ANDA204975
ndc (product): 51407-662
ndc (product): 51407-661
Fesoterodine fumarateFESOTERODINE FUMARATEDr.Reddy's Laboratories Inc.,5c5d2a97-9029-744f-c410-a4bbbe9761a82025-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204975
application number: ANDA204975
ndc (product): 43598-247
ndc (product): 43598-248

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-247Fesoterodine fumarateFesoterodine fumarateDr.Reddy's Laboratories Inc.,ANDACurrent
43598-247Fesoterodine fumarateFesoterodine fumarateDr.Reddy's Laboratories Inc.,ANDACurrent
43598-248Fesoterodine fumarateFesoterodine fumarateDr.Reddy's Laboratories Inc.,ANDACurrent
43598-248Fesoterodine fumarateFesoterodine fumarateDr.Reddy's Laboratories Inc.,ANDACurrent
51407-661Fesoterodine fumarateFesoterodine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-662Fesoterodine fumarateFesoterodine fumarateGolden State Medical Supply, Inc.ANDACurrent