Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074868
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/12/1997 ORIG-1 Approval

Label is not available on this site.

OXYBUTYNIN CHLORIDE

SYRUP;ORAL; 5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP;ORAL Prescription No AA 074520 LANNETT CO INC
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP;ORAL Prescription No AA 075137 PHARM ASSOC
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP;ORAL Prescription No AA 074868 WOCKHARDT BIO AG

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