Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075079
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription AB 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
10/31/1997 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
06/13/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/26/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/04/2011 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/09/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/06/2009 SUPPL-6 Labeling

Label is not available on this site.

02/01/2007 SUPPL-5 Labeling

Label is not available on this site.

02/23/2006 SUPPL-4 Labeling

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 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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