Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078293
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
Oxybutynin Chloride Oxybutynin Chloride 15 MG. TABLET, EXTENDED RELEASE; ORAL Prescription TBD TBD 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
05/10/2007 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/078293Orig1s000.pdf

Oxybutynin Chloride

There are no Therapeutic Equivalents.

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