FDA.reportPublic FDA data

Application 017577

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DITROPANOXYBUTYNIN CHLORIDETABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N017577-001DITROPANOXYBUTYNIN CHLORIDE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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 UTC2022-10N017577-001DITROPAN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017577-001DITROPAN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017577-001DITROPAN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017577-001DITROPAN5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

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 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEREMEDYREPACK INC.1a08a16a-f16d-4ef1-95bb-6943bcae07372026-07-28Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDETruPharma LLC7c497c6c-2448-2c80-e053-2991aa0ab8c72026-07-27Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDERISING PHARMA HOLDINGS, INC.9578b6b8-5b9d-4263-9142-39b2c7216b852026-07-21Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEATLANTIC BIOLOGICALS CORP.fe4ed76b-0009-455f-be30-47e80fc1afdf2026-07-09Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDECoupler LLC55f618d1-4463-3200-e063-6394a90a89a82026-07-06Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEStrides Pharma Science Limited9ede5def-d185-4e40-9c10-8663ac654caf2026-07-01Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAmerican Health Packaging0c71bdfb-01db-49ac-a8e9-0037df0d24af2026-06-24Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEStrides Pharma Science Limitedac10c7b7-d0cb-4068-93e2-c0e51f15866e2026-06-01Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.73d715dc-868d-4194-b668-4c39ababa6982026-05-20Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepacka5965c8b-179d-4665-8a3b-324b693607ee2026-05-19Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
oxybutynin chlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepack7db4ab81-b379-4a6d-b469-95eb9e184b562026-05-14Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAmerican Health Packaging4574b227-9726-4798-bac2-83bfb9616f092026-04-16Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEA-S Medication Solutionsb9d0e5c8-3a71-40a0-a7d3-44bc043392fa2026-02-17Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
oxybutynin chlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.a1f8be75-2eb9-4eef-8fb4-144ef2bf7ae12026-02-16Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.9a551ec5-7e80-47c9-a7b9-f458c14781742026-02-16Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEChartwell Governmental & Specialty RX, LLC.46e78c72-a5a3-472f-9125-b120fa4eee312026-01-30Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAdvagen Pharma Limited7bd31561-4c76-4c6b-819b-4925498866732026-01-14Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEA-S Medication Solutions3688227b-7655-40ca-b34b-073a39fd60f42026-01-14Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDENorthwind Health Company, LLCf330b7a0-bbe0-0f00-e053-2a95a90a37b82026-01-01Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE
Oxybutynin ChlorideOXYBUTYNIN CHLORIDENorthwind Health Company, LLC13a79659-a181-6a61-e063-6294a90ae0342025-12-26Warnings, Adverse reactionsName fallback
generic name: OXYBUTYNIN CHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
646SUPPL2012-03-26
11034SUPPL2012-03-23
13858SUPPL2011-12-20
11033SUPPL2011-12-20
13857SUPPL2011-08-10
11032SUPPL2011-08-08
40752SUPPL2009-09-14
20080SUPPL2009-09-14
11031SUPPL2009-07-23
645SUPPL2009-07-16
11030SUPPL2008-02-14
13856SUPPL2008-02-13
13855SUPPL2003-05-29
33307SUPPL2003-04-16
11029SUPPL2003-04-16