FDA.reportPublic FDA data

Application 020779

Type
NDA
Sponsor
AGOURON PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIRACEPTNELFINAVIR MESYLATETABLET;ORALEQ 250MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020779-001VIRACEPTNELFINAVIR MESYLATEEQ 250MG BASETABLET / ORALRLD, RS1997-03-14

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020779-001VIRACEPTEQ 250MG BASETABLET / ORALRLD, RS1997-03-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020779-001VIRACEPTEQ 250MG BASETABLET / ORALRLD, RS1997-03-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020779-001VIRACEPTEQ 250MG BASETABLET / ORALRLD, RS1997-03-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020779-001VIRACEPTEQ 250MG BASETABLET / ORALRLD, RS1997-03-14a50c72e98297…

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): 020779
application number: NDA020779
ndc (product): 63010-010

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52959-289VIRACEPTnelfinavir mesylateH.J. Harkins Company, Inc.NDACurrent
55289-477VIRACEPTnelfinavir mesylatePD-Rx Pharmaceuticals, Inc.NDACurrent
63010-010VIRACEPTnelfinavir mesylateAGOURONNDACurrent
63010-010VIRACEPTnelfinavir mesylateAGOURONNDACurrent
63010-010VIRACEPTnelfinavir mesylateAGOURONNDACurrent
63010-010VIRACEPTnelfinavir mesylateAGOURONNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66879SUPPL2021-03-25
66873SUPPL2021-03-25
45361SUPPL2016-09-22
45303SUPPL2016-09-15
35337SUPPL2015-04-07
3332SUPPL2015-03-31
13410SUPPL2013-06-04
3331SUPPL2013-05-31
25797SUPPL2012-04-11
35335SUPPL2012-04-09
25798SUPPL2012-02-27
35336SUPPL2012-02-24
13409SUPPL2011-03-10
25796SUPPL2011-02-28
35334SUPPL2010-05-03
13408SUPPL2010-05-03
25795SUPPL2010-04-28
3330SUPPL2010-04-28
25794SUPPL2008-11-26
35333SUPPL2008-02-14
3329SUPPL2008-02-14
35332SUPPL2007-12-03
41692SUPPL2007-08-06
41690SUPPL2007-08-06
20941SUPPL2007-08-06
20940SUPPL2007-08-06
20939SUPPL2007-08-06
20938SUPPL2007-08-06
25793SUPPL2007-01-08
35331SUPPL2006-12-28
25792SUPPL2005-10-20
35330SUPPL2005-09-30
13407SUPPL2004-06-07
3328SUPPL2004-06-07
13406SUPPL2004-04-05
25791SUPPL2004-03-24
25790SUPPL2003-08-29
35329SUPPL2003-08-28
3327SUPPL2003-07-30
41691SUPPL2003-04-30
25787SUPPL2003-04-30
25786SUPPL2003-04-30
20937SUPPL2003-04-30
35328SUPPL2003-04-04
25789SUPPL2002-02-05
3326SUPPL2002-02-05
25788SUPPL2001-04-11
20936ORIG1997-03-14