Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021733
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
09/03/2004 ORIG-1 Approval Type 6 - New Indication (no longer used) PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21733lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21733ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021733s000_CymbaltaTOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/03/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21733lbl.pdf

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