FDA.reportPublic FDA data

Application 020778

Type
NDA
Sponsor
AGOURON PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIRACEPTNELFINAVIR MESYLATEPOWDER;ORALEQ 50MG BASE/SCOOPFULNoNo

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
N020778-001VIRACEPTNELFINAVIR MESYLATEEQ 50MG BASE/SCOOPFULPOWDER / ORAL1997-03-14

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 · 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 UTC2022-09N020778-001VIRACEPTEQ 50MG BASE/SCOOPFULPOWDER / ORAL1997-03-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020778-001VIRACEPTEQ 50MG BASE/SCOOPFULPOWDER / ORAL1997-03-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020778-001VIRACEPTEQ 50MG BASE/SCOOPFULPOWDER / ORAL1997-03-14a50c72e98297…

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 reactionsName fallback
brand name: VIRACEPT
generic name: NELFINAVIR MESYLATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66878SUPPL2021-03-25
66872SUPPL2021-03-25
45360SUPPL2016-09-22
45304SUPPL2016-09-15
35327SUPPL2015-04-07
25785SUPPL2015-03-31
35326SUPPL2013-06-04
25784SUPPL2013-05-31
25782SUPPL2012-04-11
13405SUPPL2012-04-09
25783SUPPL2012-02-27
35325SUPPL2012-02-24
13404SUPPL2011-03-10
3325SUPPL2011-02-28
35324SUPPL2010-05-03
13403SUPPL2010-05-03
3324SUPPL2010-04-28
3323SUPPL2010-04-28
25781SUPPL2008-11-26
35323SUPPL2008-02-14
3322SUPPL2008-02-14
35322SUPPL2007-12-03
41689SUPPL2007-08-06
41688SUPPL2007-08-06
20935SUPPL2007-08-06
20934SUPPL2007-08-06
3321SUPPL2007-01-08
13402SUPPL2006-12-28
25780SUPPL2005-10-20
35321SUPPL2005-09-30
25779SUPPL2004-06-07
13401SUPPL2004-06-07
13400SUPPL2004-04-05
25778SUPPL2004-03-24
25777SUPPL2003-08-29
35320SUPPL2003-08-28
25776SUPPL2003-07-30
35319SUPPL2003-04-04
3320SUPPL2002-02-05
3319SUPPL2002-02-05
25775SUPPL2001-04-11
20933ORIG1997-03-14
52064ORIG1900-01-01
52063ORIG1900-01-01
52062ORIG1900-01-01
52061ORIG1900-01-01