Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210125
Company: TULEX PHARMS INC

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
09/06/2018 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 PHARMA LLC
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 211682 EMCURE PHARMS LTD
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 211062 INVATECH PHARMA
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 209823 NOVITIUM 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
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 075079 VINTAGE PHARMS

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