Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022148
Company: LILLY

• Summary Review

Products on NDA 022148

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022148

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2008	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/2008/022148lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022148s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022148_cymbalta_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022148s000_SumR.pdf

Labels for NDA 022148

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022148lbl.pdf