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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021503-001VIRACEPTNELFINAVIR MESYLATEEQ 625MG BASETABLET / ORALRLD, RS2003-04-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N021503-001VIRACEPTEQ 625MG BASETABLET / ORALRLD, RS2003-04-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021503-001VIRACEPTEQ 625MG BASETABLET / ORALRLD, RS2003-04-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021503-001VIRACEPTEQ 625MG BASETABLET / ORALRLD, RS2003-04-30a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIRACEPTNELFINAVIR MESYLATEAGOURONe72c2bc6-9462-4a2e-8e1d-b97592376cbd2025-12-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 021503
application number: NDA021503
ndc (product): 63010-027

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

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