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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211062
Company: EYWA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET;ORAL Prescription BX 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
02/06/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

OXYBUTYNIN CHLORIDE

There are no Therapeutic Equivalents.

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