Orange Book product · Generic (ANDA)
OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE
At a glance
Oct 15, 1997
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 15, 1997
29 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYBUTYNIN CHLORIDE
Strength
5MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
ANDA 074997
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OXYBUTYNIN CHLORIDE
- 2009GELNIQUEBrand (NDA)
NDA 022204 · ABBVIE
- 1998DITROPAN XLBrand (NDA)
NDA 020897 · JANSSEN PHARMS
- —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
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.
