Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076702
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;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
11/09/2006 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076702s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/076702Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/19/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

08/19/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

01/22/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

01/22/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/26/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/29/2013 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

03/01/2011 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/19/2009 SUPPL-7 Labeling

Label is not available on this site.

OXYBUTYNIN CHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DITROPAN XL OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020897 JANSSEN PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207138 ACCORD HLTHCARE
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211655 AJANTA PHARMA LTD
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204010 AMNEAL PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076745 IMPAX PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076702 MYLAN
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078503 OSMOTICA PHARM US
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206121 UNIQUE PHARM LABS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202332 ZYDUS PHARMS

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