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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071655
Company: TEVA PHARMS USA
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
11/14/1988 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-25 Labeling-Package Insert

Label is not available on this site.

10/28/2011 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

03/09/2010 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

02/19/2008 SUPPL-15 Labeling

Label is not available on this site.

05/29/2001 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

03/20/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/2001 SUPPL-10 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/24/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/11/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/04/1992 SUPPL-4 Labeling

Label is not available on this site.

02/27/1992 SUPPL-3 Labeling

Label is not available on this site.

02/21/1990 SUPPL-2 Labeling

Label is not available on this site.

02/15/1994 SUPPL-1 Manufacturing (CMC)

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
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 213550 BEXIMCO PHARMS USA
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 212798 LEADING
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 075079 STRIDES PHARMA
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription No AB 208165 STRIDES 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
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