Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074625
Company: UPSHER SMITH LABS
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
07/31/1996 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
07/31/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

04/26/2012 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

04/26/2012 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

03/03/2010 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

01/06/2009 SUPPL-14 Labeling

Label is not available on this site.

12/17/2006 SUPPL-10 Labeling

Label is not available on this site.

01/08/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/30/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/03/1996 SUPPL-1 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 ARISE
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 211062 ATHEM
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 211682 EMCURE PHARMS LTD
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 210611 NOVAST LABS
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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