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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075039
Company: CHARTWELL RX

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
01/29/1999 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/26/2006 SUPPL-4 Labeling

Label is not available on this site.
08/13/2002 SUPPL-1 Manufacturing (CMC)-Facility

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 075039 CHARTWELL RX
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG/5ML SYRUP;ORAL Prescription No AA 074520 LANNETT CO INC
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