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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022332
Company: ELI LILLY CO

Products on NDA 022332

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADCIRCA	TADALAFIL	20MG	TABLET;ORAL	Prescription	AB2	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022332

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2009	ORIG-1	Approval	Type 6 - New Indication (no longer used)	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022332s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022332_adcirca_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2020	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022332Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022332Orig1s011ltr.pdf
05/05/2017	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022332s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022332Orig1s009ltr.pdf
04/02/2015	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022332s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022332Orig1s007ltr.pdf
04/29/2014	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022332s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022332Orig1s006ltr.pdf
11/20/2013	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022332s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022332Orig1s005ltr.pdf
02/08/2011	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022332s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022332s003ltr.pdf

Labels for NDA 022332

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2020	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022332Orig1s011lbl.pdf
05/05/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022332s009lbl.pdf
04/02/2015	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022332s007lbl.pdf
04/29/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022332s006lbl.pdf
11/20/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022332s005lbl.pdf
02/08/2011	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022332s003lbl.pdf
05/22/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf

Therapeutic Equivalents for NDA 022332

ADCIRCA

TABLET;ORAL; 20MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADCIRCA	TADALAFIL	20MG	TABLET;ORAL	Prescription	Yes	AB2	022332	ELI LILLY CO
ALYQ	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	216932	TEVA PHARMS INC
ALYQ	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	209942	TEVA PHARMS USA
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	210392	AJANTA PHARMA LTD
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	206286	AUROBINDO PHARMA LTD
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	210572	CHARTWELL RX
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	210255	CIPLA
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	210145	DR REDDYS
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	209907	HETERO LABS LTD III
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	207290	MACLEODS PHARMS LTD
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	210608	PRINSTON INC
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	213496	SUNSHINE
TADALAFIL	TADALAFIL	20MG	TABLET;ORAL	Prescription	No	AB2	212062	TORRENT

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