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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209025
Company: APPCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

OXYBUTYNIN CHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 209335 ABHAI LLC
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 209025 APPCO
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 213550 BEXIMCO PHARMS USA
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 212798 LEADING
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 210611 NOVAST LABS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 209823 NOVITIUM PHARMA
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 075079 STRIDES PHARMA
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 208165 STRIDES PHARMA
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 071655 TEVA PHARMS USA
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 210125 TULEX PHARMS INC
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 074625 UPSHER SMITH LABS
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