FDA.reportPublic FDA data

Application 090526

Type
ANDA
Sponsor
BARR LABS DIV TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNINOXYBUTYNINFILM, EXTENDED RELEASE;TRANSDERMAL3.9MG/24HRNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090526-001OXYBUTYNINOXYBUTYNIN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2014-03-04

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090526-001OXYBUTYNIN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2014-03-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090526-001OXYBUTYNIN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2014-03-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090526-001OXYBUTYNIN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2014-03-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090526-001OXYBUTYNIN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2014-03-04a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxybutyninOXYBUTYNINZydus Lifesciences Limitedf405a774-bd91-4513-b7c7-c44f0596d9882024-12-03Name fallback
brand name: oxybutynin
generic name: OXYBUTYNIN
oxybutyninOXYBUTYNINNCS HealthCare of KY, LLC dba Vangard Labsec4fd95f-16dc-4acf-b560-b67b7aaef08b2024-09-13Warnings, Adverse reactionsName fallback
brand name: oxybutynin
generic name: OXYBUTYNIN
Oxytrol for WomenOXYBUTYNINAllergan, Inc.8cdc5b4d-ff8d-4010-97d7-313422a0b8682024-08-15WarningsName fallback
generic name: OXYBUTYNIN
oxybutyninOXYBUTYNINNCS HealthCare of KY, LLC dba Vangard Labsed10f0c9-23d6-4ded-b17f-ed474632a9652024-08-12Warnings, Adverse reactionsName fallback
brand name: oxybutynin
generic name: OXYBUTYNIN
OXYTROLOXYBUTYNINAllergan, Inc.20dee37f-1412-44ed-9e8b-f4379ce23eb02024-05-29Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN
oxybutyninOXYBUTYNINZydus Pharmaceuticals USA Inc.c042bf06-79a3-4dc7-ae05-3ef3cfae9d442023-11-07Warnings, Adverse reactionsName fallback
brand name: oxybutynin
generic name: OXYBUTYNIN
oxybutyninOXYBUTYNINA-S Medication Solutions1f95920c-5dc2-44e4-b61d-b2c5e05390ba2023-02-06Warnings, Adverse reactionsName fallback
brand name: oxybutynin
generic name: OXYBUTYNIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9272ORIG2014-03-06