Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090775
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE 20MG CAPSULE, DELAYED RELEASE; ORAL None (Tentative Approval) None No No
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE 30MG CAPSULE, DELAYED RELEASE; ORAL None (Tentative Approval) None No No
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE 60MG CAPSULE, DELAYED RELEASE; ORAL None (Tentative Approval) None 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
02/02/2011 ORIG-1 Tentative Approval

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