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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021368
Company: LILLY

Other Important Information from FDA

Products on NDA 21368

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIALIS	TADALAFIL	5MG	TABLET;ORAL	Prescription	AB1	Yes	No
CIALIS	TADALAFIL	10MG	TABLET;ORAL	Prescription	AB1	Yes	No
CIALIS	TADALAFIL	20MG	TABLET;ORAL	Prescription	AB1	Yes	Yes
CIALIS	TADALAFIL	2.5MG	TABLET;ORAL	Prescription	AB1	Yes	No

Labels for NDA 021368

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2018	SUPPL-30	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021368s030lbl.pdf
05/05/2017	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021368s029lbl.pdf
04/22/2016	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021368s027lbl.pdf
09/16/2015	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021368s026lbl.pdf
04/29/2014	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021368s023lbl.pdf
10/10/2013	SUPPL-22	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021368s022lbl.pdf
10/06/2011	SUPPL-21	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf
10/06/2011	SUPPL-20	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf
02/01/2010	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021368s017lbl.pdf
01/07/2008	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021368s011lbl.pdf
10/18/2007	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s012lbl.pdf
01/22/2007	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s007lbl.pdf
10/23/2006	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf
10/23/2006	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf
03/07/2006	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s008lbl.pdf
07/08/2005	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s006lbl.pdf
03/31/2005	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf
03/31/2005	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf
11/21/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021368lbl.pdf

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