Nelfinavir Oral Tablet

Brand(s)
Viracept
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Agouron (2015-04-14)
Oldest Current Product
1997-03-14
License(s)
NDA
RxNORM
ORAL TABLET\NELFINAVIR
FDAOB
ORAL\TABLET\NELFINAVIR MESYLATE
SPL Active
ORAL\TABLET, FILM COATED\NELFINAVIR MESYLATE
SPL Moiety
ORAL\TABLET, FILM COATED\NELFINAVIR

product(s) by strength(s)

nelfinavir 250 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1630100010ViraceptNDAAgouron1997-03-14NELFINAVIR MESYLATEORALTABLET, FILM COATEDNDA020779e72c2bc6-9462-4a2e-8e1d-b97592376cbd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1529590289ViraceptNDAH.J. Harkins Company, Inc.1997-03-14NELFINAVIR MESYLATEORALTABLET, FILM COATED630100010NDA020779303c9bc8-eaff-4a65-9c60-7de6bddec348
2552890477ViraceptNDAPd-Rx Pharmaceuticals, Inc.1997-03-14NELFINAVIR MESYLATEORALTABLET, FILM COATED630100010NDA02077991152af4-a9c8-4b14-acbb-e4b6f2be145a

nelfinavir 625 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1630100027ViraceptNDAAgouron2003-04-30NELFINAVIR MESYLATEORALTABLET, FILM COATEDNDA021503e72c2bc6-9462-4a2e-8e1d-b97592376cbd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1242360287ViraceptNDARemedyrepack Inc.2013-03-27NELFINAVIR MESYLATEORALTABLET, FILM COATED630100027NDA02150384948e6a-971f-4e86-928e-7d32a1883a23
2538080809ViraceptNDAState Of Florida Doh Central Pharmacy2009-07-01NELFINAVIR MESYLATEORALTABLET, FILM COATED630100027NDA0215039b370904-d2cd-4585-bc48-a8110621c8bd

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020779VIRACEPTAGOURON PHARMACEUTICALS INC1997-03-14NDA020779_001
2NDA021503VIRACEPTAGOURON PHARMACEUTICALS INC2003-04-30NDA021503_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020779_001RXNELFINAVIR MESYLATE (EQ 250MG BASE)ORALTABLETTrue1997-03-14VIRACEPT
2NDA021503_001RXNELFINAVIR MESYLATE (EQ 625MG BASE)ORALTABLETTrue2003-04-30VIRACEPT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1303c9bc8-eaff-4a65-9c60-7de6bddec348 (view SPL)VIRACEPT (nelfinavir mesylate) TABLETS and ORAL POWDERprescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2012-04-183529590289
284948e6a-971f-4e86-928e-7d32a1883a23 (view SPL)These highlights do not include all the information needed to use VIRACEPT safely and effectively. See full prescribing information for VIRACEPT. VIRACEPT (nelfinavir mesylate) Tablets, for oral use VIRACEPT (nelfinavir mesylate) Oral Powder, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionRemedyrepack Inc.2013-03-271242360287
391152af4-a9c8-4b14-acbb-e4b6f2be145a (view SPL)VIRACEPT (nelfinavir mesylate) TABLETS and ORAL POWDERprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-04-2116552890477
49b370904-d2cd-4585-bc48-a8110621c8bd (view SPL)VIRACEPT (nelfinavir mesylate) TABLETS and ORAL POWDERprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-04-131538080809
5e72c2bc6-9462-4a2e-8e1d-b97592376cbd (view SPL)These highlights do not include all the information needed to use VIRACEPT safely and effectively. See full prescribing information for VIRACEPT. VIRACEPT (nelfinavir mesylate) Tablets, for oral use VIRACEPT (nelfinavir mesylate) Oral Powder, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionAgouronAPI MANUFACTURE, MANUFACTURE, PACK2015-04-1422630100010, 630100027, 630100011Nelfinavir Oral Powder

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII