`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS&APPLNO=021845)
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`PRODUCTS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS&APPLNO=021845)
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`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 021845
`Company: PFIZER
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021845)
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`Patient Information Sheet (http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021845s002PI.pdf)
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`Other Important Information from FDA (http://www.fda.gov/Drugs/DrugSafety/ucm390876.htm)
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`Products on NDA 021845
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`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`REVATIO
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`SILDENAFIL
`CITRATE
`Showing 1 to 1 of 1 entries
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`Dosage
`Form/Route
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`Marketing
`Status
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`TE
`Code
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`RLD
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`TABLET;ORAL
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`Prescription
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`Yes
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`AB
`
`Strength
`
`EQ 20MG
`BASE
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`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021845
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021845
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1094, p. 1 of 3
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`Drugs@FDA: FDA Approved Drug Products
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`Review
`Priority;
`Orphan
`Status
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`PRIORITY
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`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`Action
`Date
`
`Submission
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`Action
`Type
`
`Submission
`Classification
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`06/03/2005 ORIG1
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`Approval
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`Type 5 New
`Formulation or
`New
`Manufacturer
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`Showing 1 to 1 of 1 entries
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`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`Submission
`Classification
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`Letters, Reviews, Labels, Patient Package Insert
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021845lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021845ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021845s000_RevatioTOC.cfm)
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`Letters, Reviews, Labels,
`Patient Package Insert
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`04/27/2015 SUPPL16
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`Labeling
`Package Insert
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,203109s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473Orig1s010,203109Origs009ltr.pdf)
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`02/03/2015 SUPPL9
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`Manufacturing
`(CMC)
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`03/11/2014
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`SUPPL11
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`Labeling
`Package Insert
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473Orig1s004,203109Origs002ltr.pdf)
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`03/06/2014 SUPPL14
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`01/31/2014 SUPPL13
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`01/31/2014 SUPPL12
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`08/30/2012 SUPPL8
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`Labeling
`Package Insert
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`Labeling
`Package Insert
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`Efficacy
`Labeling
`Change With
`Clinical Data
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`Efficacy
`Labeling
`Change With
`Clinical Data
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s014,022473s007,203109s005lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473Orig1s007,203109Orig1s005ltr.pdf)
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf)
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf)
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021845s008lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021845Orig1s008ltr.pdf)
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021845
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`2/3
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1094, 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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`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`11/19/2010
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`SUPPL7
`
`Labeling
`Package Insert
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021845s007,022473s001lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021845s007,022473s001ltr.pdf)
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`05/07/2009 SUPPL6
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`EfficacyNew
`Indication
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s006lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021845s006ltr.pdf)
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`02/17/2009 SUPPL5
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`Labeling
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s005lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021845s005ltr.pdf)
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`12/18/2007 SUPPL4
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`Labeling
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021845s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021845s004ltr.pdf)
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`07/27/2006 SUPPL2
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`Labeling
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`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021845s002ltr.pdf)
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`07/19/2006 SUPPL3
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`Labeling
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`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021845s003_ltr.pdf)
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`11/03/2005
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`SUPPL1
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`Labeling
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`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021845s001ltr.pdf)
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`Showing 1 to 14 of 14 entries
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`Labels for NDA 021845
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`Therapeutic Equivalents for NDA 021845
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`
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021845
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1094, p. 3 of 3
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