Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021368
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIALIS TADALAFIL 5MG TABLET;ORAL Prescription AB Yes No
CIALIS TADALAFIL 10MG TABLET;ORAL Prescription AB Yes No
CIALIS TADALAFIL 20MG TABLET;ORAL Prescription AB1 Yes Yes
CIALIS TADALAFIL 2.5MG TABLET;ORAL Prescription AB Yes 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
11/21/2003 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021368lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21368ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021368ppilbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-368_Cialis.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021368s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021368Orig1s030ltr.pdf
05/05/2017 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021368s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021368Orig1s029ltr.pdf
07/12/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/22/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021368s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021368Orig1s027ltr.pdf
09/16/2015 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021368s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021368Orig1s026ltr.pdf
09/01/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/29/2014 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021368s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021368Orig1s023ltr.pdf
10/10/2013 SUPPL-22 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021368s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021368Orig1s022ltr.pdf
10/06/2011 SUPPL-21 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021368s020,s021ltr.pdf
10/06/2011 SUPPL-20 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021368s020,s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021368Orig1s020.pdf
02/01/2010 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021368s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021368s017ltr.pdf
08/07/2008 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021368s013ltr.pdf
10/18/2007 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021368s012ltr.pdf
01/07/2008 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021368s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021368s011ltr.pdf
10/23/2006 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s009, s010ltr.pdf
10/23/2006 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s009, s010ltr.pdf
03/07/2006 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s008ltr.pdf
01/22/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021368s007ltr.pdf
07/08/2005 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s006ltr.pdf
03/31/2005 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s004,005ltr.pdf
03/31/2005 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s004,005ltr.pdf
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

CIALIS

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIALIS TADALAFIL 5MG TABLET;ORAL Prescription Yes AB 021368 LILLY
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209167 ACCORD HLTHCARE
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209654 AJANTA PHARMA LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 204809 ALEMBIC PHARMS LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209744 AMNEAL PHARMS CO
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 206285 AUROBINDO PHARMA LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209539 CIPLA
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 210069 DR REDDYS LABS LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209908 HETERO LABS LTD III
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 210567 LUPIN LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 207244 MACLEODS PHARMS LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 206957 MYLAN
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 210420 QILU PHARM CO LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 208934 SUN PHARM
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 211335 SUNSHINE LAKE
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 090141 TEVA PHARMS USA
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 211839 TORRENT
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 209250 UNICHEM LABS LTD
TADALAFIL TADALAFIL 5MG TABLET;ORAL Prescription No AB 206693 ZYDUS PHARMS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIALIS TADALAFIL 10MG TABLET;ORAL Prescription Yes AB 021368 LILLY
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 209654 AJANTA PHARMA LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 204809 ALEMBIC PHARMS LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 209744 AMNEAL PHARMS CO
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 206285 AUROBINDO PHARMA LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 209539 CIPLA
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 210069 DR REDDYS LABS LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 209908 HETERO LABS LTD III
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 210567 LUPIN LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 207244 MACLEODS PHARMS LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 206956 MYLAN
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 210420 QILU PHARM CO LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 208934 SUN PHARM
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 211335 SUNSHINE LAKE
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 090141 TEVA PHARMS USA
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 211839 TORRENT
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 209250 UNICHEM LABS LTD
TADALAFIL TADALAFIL 10MG TABLET;ORAL Prescription No AB 206693 ZYDUS PHARMS

TABLET;ORAL; 20MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIALIS TADALAFIL 20MG TABLET;ORAL Prescription Yes AB1 021368 LILLY
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209167 ACCORD HLTHCARE
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209654 AJANTA PHARMA LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 204809 ALEMBIC PHARMS LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209744 AMNEAL PHARMS CO
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 206285 AUROBINDO PHARMA LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209539 CIPLA
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 210069 DR REDDYS LABS LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209908 HETERO LABS LTD III
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 210567 LUPIN LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 207244 MACLEODS PHARMS LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 206956 MYLAN
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 210420 QILU PHARM CO LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 208934 SUN PHARM
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 211335 SUNSHINE LAKE
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 090141 TEVA PHARMS USA
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 211839 TORRENT
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 209250 UNICHEM LABS LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB1 206693 ZYDUS PHARMS

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIALIS TADALAFIL 2.5MG TABLET;ORAL Prescription Yes AB 021368 LILLY
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209167 ACCORD HLTHCARE
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209654 AJANTA PHARMA LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 204809 ALEMBIC PHARMS LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209744 AMNEAL PHARMS CO
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 206285 AUROBINDO PHARMA LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209539 CIPLA
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 210069 DR REDDYS LABS LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209908 HETERO LABS LTD III
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 210567 LUPIN LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 207244 MACLEODS PHARMS LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 206956 MYLAN
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 210420 QILU PHARM CO LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 208934 SUN PHARM
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 211335 SUNSHINE LAKE
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 090141 TEVA PHARMS USA
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 211839 TORRENT
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 209250 UNICHEM LABS LTD
TADALAFIL TADALAFIL 2.5MG TABLET;ORAL Prescription No AB 206693 ZYDUS PHARMS

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