FDA.reportPublic FDA data

Application 021503

Type
NDA
Sponsor
AGOURON PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIRACEPTNELFINAVIR MESYLATETABLET;ORALEQ 625MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53808-0809ViraceptNELFINAVIR MESYLATEState of Florida DOH Central PharmacyNDACurrent
63010-027VIRACEPTnelfinavir mesylateAGOURONNDACurrent
63010-027VIRACEPTnelfinavir mesylateAGOURONNDACurrent
63010-027VIRACEPTnelfinavir mesylateAGOURONNDACurrent
63010-027VIRACEPTnelfinavir mesylateAGOURONNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66880SUPPL2021-03-25
66874SUPPL2021-03-25
45359SUPPL2016-09-22
45302SUPPL2016-09-20
15622SUPPL2015-04-07
27949SUPPL2015-03-31
15621SUPPL2013-06-04
27948SUPPL2013-05-31
27947SUPPL2012-04-11
37084SUPPL2012-04-09
5564SUPPL2012-02-27
15620SUPPL2012-02-24
15619SUPPL2011-03-04
27946SUPPL2011-02-28
37083SUPPL2010-05-03
15618SUPPL2010-05-03
27945SUPPL2010-04-28
5563SUPPL2010-04-28
5562SUPPL2008-11-26
27944SUPPL2008-02-14
15617SUPPL2008-02-14
21702SUPPL2007-08-06
21701SUPPL2007-08-06
15616SUPPL2007-08-02
27943SUPPL2007-01-08
37082SUPPL2006-12-28
21700ORIG2005-12-16
5561SUPPL2005-10-20
15615SUPPL2005-09-30
15614SUPPL2004-06-07
5560SUPPL2004-06-07
15612SUPPL2004-04-05
27941SUPPL2004-03-24
27942SUPPL2003-08-29
15613SUPPL2003-08-28
5559ORIG2003-05-29
15611ORIG2003-05-06