FDA.reportPublic FDA data

Application 020895

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIAGRASILDENAFIL CITRATETABLET;ORALEQ 25MG BASEYesNo
002VIAGRASILDENAFIL CITRATETABLET;ORALEQ 50MG BASEYesNo
003VIAGRASILDENAFIL CITRATETABLET;ORALEQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-4200Viagrasildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4200Viagrasildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4200Viagrasildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4210Viagrasildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4210Viagrasildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4210Viagrasildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4220Viagrasildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4220Viagrasildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
0069-4220Viagrasildenafil citratePfizer Laboratories Div Pfizer IncNDACurrent
21695-157Viagrasildenafil citrateRebel Distributors CorpNDACurrent
21695-158Viagrasildenafil citrateRebel Distributors CorpNDACurrent
43063-256Viagrasildenafil citratePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-256Viagrasildenafil citratePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-256Viagrasildenafil citratePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-256Viagrasildenafil citratePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-256Viagrasildenafil citratePD-Rx Pharmaceuticals, Inc.NDACurrent
43353-764Viagrasildenafil citrateAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-764Viagrasildenafil citrateAphena Pharma Solutions - Tennessee, LLCNDACurrent
50090-0619Viagrasildenafil citrateA-S Medication SolutionsNDACurrent
50090-0619Viagrasildenafil citrateA-S Medication SolutionsNDACurrent
50436-0035Sildenafil Citratesildenafil citrateUnit Dose ServicesNDACurrent
50436-0035Sildenafil Citratesildenafil citrateUnit Dose ServicesNDACurrent
50436-0036Sildenafil Citratesildenafil citrateUnit Dose ServicesNDACurrent
50436-3500Sildenafil Citratesildenafil citrateUnit Dose ServicesNDACurrent
55154-2736Viagrasildenafil citrateCardinal HealthNDACurrent
55289-524Viagrasildenafil citratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-577Viagrasildenafil citratePD-Rx Pharmaceuticals, Inc.NDACurrent
59762-0034Sildenafil Citratesildenafil citrateGreenstone LLCNDACurrent
59762-0034Sildenafil Citratesildenafil citrateGreenstone LLCNDACurrent
59762-0034Sildenafil Citratesildenafil citrateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0034Sildenafil Citratesildenafil citrateGreenstone LLCNDACurrent
59762-0035Sildenafil Citratesildenafil citrateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0035Sildenafil Citratesildenafil citrateGreenstone LLCNDACurrent
59762-0035Sildenafil Citratesildenafil citrateGreenstone LLCNDACurrent
59762-0035Sildenafil Citratesildenafil citrateGreenstone LLCNDACurrent
59762-0036Sildenafil Citratesildenafil citrateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0036Sildenafil Citratesildenafil citrateGreenstone LLCNDACurrent
59762-0036Sildenafil Citratesildenafil citrateGreenstone LLCNDACurrent
59762-0036Sildenafil Citratesildenafil citrateGreenstone LLCNDACurrent
63539-421Viagrasildenafil citrateU.S. PharmaceuticalsNDACurrent
63539-421Viagrasildenafil citrateU.S. PharmaceuticalsNDACurrent
63539-421Viagrasildenafil citrateU.S. PharmaceuticalsNDACurrent
63539-422Viagrasildenafil citrateU.S. PharmaceuticalsNDACurrent
63539-422Viagrasildenafil citrateU.S. PharmaceuticalsNDACurrent
63539-422Viagrasildenafil citrateU.S. PharmaceuticalsNDACurrent
63629-6316Viagrasildenafil citrateBryant Ranch PrepackNDACurrent
63629-6316Viagrasildenafil citrateBryant Ranch PrepackNDACurrent
63629-6369Viagrasildenafil citrateBryant Ranch PrepackNDACurrent
63629-6369Viagrasildenafil citrateBryant Ranch PrepackNDACurrent
63629-7273Viagrasildenafil citrateBryant Ranch PrepackNDACurrent
63629-7273Viagrasildenafil citrateBryant Ranch PrepackNDACurrent
63629-7273Viagrasildenafil citrateBryant Ranch PrepackNDACurrent
63629-7273Viagrasildenafil citrateBryant Ranch PrepackNDACurrent
67544-355Viagrasildenafil citrateAphena Pharma Solutions - Tennessee, LLCNDACurrent
67544-355Viagrasildenafil citrateAphena Pharma Solutions - Tennessee, LLCNDACurrent
67544-356Viagrasildenafil citrateAphena Pharma Solutions - Tennessee, LLCNDACurrent
67544-356Viagrasildenafil citrateAphena Pharma Solutions - Tennessee, LLCNDACurrent
70518-0953Viagrasildenafil citrateREMEDYREPACK INC.NDACurrent
70518-0953Viagrasildenafil citrateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50711SUPPL2017-12-15
50687SUPPL2017-12-14
49505SUPPL2017-08-22
49445SUPPL2017-08-17
13683SUPPL2015-09-23
3670SUPPL2015-09-17
35582SUPPL2015-03-27
26131SUPPL2015-03-27
35581SUPPL2014-03-11
35580SUPPL2014-03-11
26130SUPPL2014-03-11
3669SUPPL2014-03-11
3668SUPPL2011-02-04
35579SUPPL2011-01-31
13682SUPPL2010-01-20
3667SUPPL2010-01-15
21046ORIG2009-04-13
3666SUPPL2008-08-13
3665SUPPL2008-08-13
3663SUPPL2008-02-27
13681SUPPL2008-02-26
41785SUPPL2008-02-19
41784SUPPL2008-02-19
21047SUPPL2008-02-19
23608ORIG2007-10-30
3664SUPPL2007-10-22
35578SUPPL2007-10-18
26129SUPPL2006-10-13
13680SUPPL2006-10-11
3662SUPPL2006-07-03
13678SUPPL2006-06-28
26128SUPPL2005-07-15
13679SUPPL2005-07-08
35577SUPPL2002-09-19
26127SUPPL2002-09-19
26126SUPPL2002-09-19
13677SUPPL2002-09-19
13676SUPPL2002-09-19
3661SUPPL2002-09-19
13675ORIG1998-03-27
3660ORIG1998-03-27
64081ORIG1900-01-01
64080ORIG1900-01-01
64079ORIG1900-01-01
64078ORIG1900-01-01
64077ORIG1900-01-01
64076ORIG1900-01-01
64074ORIG1900-01-01