Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022516
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYMBALTA DULOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS; ORAL Prescription None No No
CYMBALTA DULOXETINE HYDROCHLORIDE EQ 30MG BASE CAPSULE, DELAYED REL PELLETS; ORAL Prescription None No No
CYMBALTA DULOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE, DELAYED REL PELLETS; ORAL Prescription 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
11/04/2010 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022516lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022516s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022516_cymbalta_tocEDT.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022516Orig1s000SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/04/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022516lbl.pdf

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