Saquinavir Oral Capsule

Brand(s)
Invirase
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-04-30)
Oldest Current Product
1995-12-06
License(s)
NDA
RxNORM
ORAL CAPSULE\SAQUINAVIR
FDAOB
ORAL\CAPSULE\SAQUINAVIR MESYLATE
SPL Active
ORAL\CAPSULE\SAQUINAVIR MESYLATE
SPL Moiety
ORAL\CAPSULE\SAQUINAVIR

product(s) by strength(s)

saquinavir 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040245InviraseNDAGenentech, Inc.1995-12-06SAQUINAVIR MESYLATEORALCAPSULENDA020628c00d1607-ac36-457b-a34b-75ad74f9cf0a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490624InviraseNDARemedyrepack Inc.2013-05-01SAQUINAVIR MESYLATEORALCAPSULE000040245NDA02062809f4482d-75a8-4c98-bd00-08108da675c8

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA020628INVIRASEHOFFMANN LA ROCHE INC1995-12-06PEDIATRIC EXCLUSIVITY [2016-05-30]
REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST [2015-11-30]
NDA020628_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020628_001RXSAQUINAVIR MESYLATE (EQ 200MG BASE)ORALCAPSULETrue1995-12-06INVIRASE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
109f4482d-75a8-4c98-bd00-08108da675c8 (view SPL)These highlights do not include all the information needed to use INVIRASE safely and effectively. See full prescribing information for INVIRASE. INVIRASE (saquinavir mesylate) Capsules and Tablets, for oral use Initial U.S. Approval: 1995 (Capsules) and 2004 (Tablets)prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-011493490624
2c00d1607-ac36-457b-a34b-75ad74f9cf0a (view SPL)These highlights do not include all the information needed to use INVIRASE safely and effectively. See full prescribing information for INVIRASE. INVIRASE (saquinavir mesylate) capsules and tablets, for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-04-3016000040245, 000040244Saquinavir Oral Tablet

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