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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075137
Company: PHARM ASSOC
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 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
12/18/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75137ltr.pdf

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
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