Orange Book product · Brand (NDA)
DITROPAN XL
OXYBUTYNIN CHLORIDE
At a glance
Dec 16, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 16, 1998
27 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYBUTYNIN CHLORIDE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 020897
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2009GELNIQUEBrand (NDA)
NDA 022204 · ABBVIE
- —DITROPANBrand (NDA)
NDA 018211 · ORTHO MCNEIL JANSSEN
- —DITROPANBrand (NDA)
NDA 017577 · JANSSEN PHARMS
- 2026OXYBUTYNIN CHLORIDEGeneric (ANDA)
ANDA 075079 · STRIDES PHARMA INTL
- 2023OXYBUTYNIN CHLORIDEGeneric (ANDA)
ANDA 209025 · RISING
- 2022OXYBUTYNIN CHLORIDEGeneric (ANDA)
ANDA 213550 · REGCON HOLDINGS
- 2020OXYBUTYNIN CHLORIDEGeneric (ANDA)
ANDA 208165 · STRIDES PHARMA
- 2020OXYBUTYNIN CHLORIDEGeneric (ANDA)
ANDA 214415 · RUBICON RESEARCH
- 2020OXYBUTYNIN CHLORIDEGeneric (ANDA)
ANDA 212798 · LEADING
- 2019OXYBUTYNIN CHLORIDEGeneric (ANDA)
ANDA 210717 · BIONPHARMA
- 2019OXYBUTYNIN CHLORIDEGeneric (ANDA)
ANDA 210611 · NOVAST LABS
- 2019OXYBUTYNIN CHLORIDEGeneric (ANDA)
ANDA 211682 · AVET LIFESCIENCES
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
