FDA.reportPublic FDA data

Application 204946

Type
ANDA
Sponsor
ZYDUS PHARMS

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
A204946-001FESOTERODINE FUMARATEFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2017-10-03
A204946-002FESOTERODINE FUMARATEFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2017-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204946-001AB
A204946-002AB

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 22:54:322026-06A204946-001FESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALAB2017-10-03a50c72e98297…
2026-08-01 22:54:322026-06A204946-002FESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALAB2017-10-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204946-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204946-002AB1a50c72e98297…

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 FUMARATEZydus Pharmaceuticals USA Inc.8c68e918-b47b-466d-80bc-4f521aa746072025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204946
application number: ANDA204946
ndc (product): 68382-480
ndc (product): 68382-479
fesoterodine fumarateFESOTERODINE FUMARATEZydus Lifesciences Limited26e8cc63-1e1d-4a77-8f53-4c38bcf0d4432024-11-30Exact identifier
application applno (ANDA): 204946
application number: ANDA204946
ndc (product): 70771-1169
ndc (product): 70771-1168

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-479fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-479fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-479fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-479fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-479fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-480fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-480fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-480fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-480fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-480fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1168fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1168fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1168fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1168fesoterodine fumaratefesoterodine fumarateZydus Lifesciences LimitedANDACurrent
70771-1169fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1169fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1169fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1169fesoterodine fumaratefesoterodine fumarateZydus Lifesciences LimitedANDACurrent