`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`New Drug Application (NDA): 022332
`Company: ELI LILLY CO
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
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`
`Products on NDA 022332
`
`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`TADALAFIL
`ADCIRCA
`Showing 1 to 1 of 1 entries
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`20MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`None
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022332
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`
`
`
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1087, p. 1 of 3
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`5/17/2017
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`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`05/22/2009 ORIG1
`
`Approval
`
`Type 6 New
`Indication (no
`longer used)
`
`STANDARD Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022332s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022332_adcirca_toc.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`05/05/2017 SUPPL9
`
`Submission
`Classification
`
`Labeling
`Package Insert
`
`04/02/2015 SUPPL7
`
`Labeling
`Package Insert
`
`04/29/2014 SUPPL6
`
`Labeling
`Package Insert
`
`11/20/2013
`
`SUPPL5
`
`Labeling
`Package Insert
`
`02/08/2011
`
`SUPPL3
`
`Labeling
`Package Insert
`
`Showing 1 to 5 of 5 entries
`
`Labels for NDA 022332
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022332s009lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022332Orig1s009ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022332s007lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022332Orig1s007ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022332s006lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022332Orig1s006ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022332s005lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022332Orig1s005ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022332s003lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022332s003ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1087, p. 2 of 3
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`5/17/2017
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`Drugs@FDA: FDA Approved Drug Products
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1087, p. 3 of 3
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