Indinavir Oral Capsule

Brand(s)
Crixivan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-03-27)
Oldest Current Product
1996-03-13
License(s)
NDA
RxNORM
ORAL CAPSULE\INDINAVIR
FDAOB
ORAL\CAPSULE\INDINAVIR SULFATE
SPL Active
ORAL\CAPSULE\INDINAVIR SULFATE
SPL Moiety
ORAL\CAPSULE\INDINAVIR
ORAL\CAPSULE\INDINAVIR ANHYDROUS

product(s) by strength(s)

indinavir 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060571CrixivanNDAMerck Sharp & Dohme Corp.1996-03-13INDINAVIR SULFATEORALCAPSULENDA020685e19405d9-d9a1-4072-5b9e-40cd3ae4bf1f

indinavir 400 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060573CrixivanNDAMerck Sharp & Dohme Corp.1996-03-13INDINAVIR SULFATEORALCAPSULENDA020685e19405d9-d9a1-4072-5b9e-40cd3ae4bf1f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900064CrixivanNDAStat Rx Usa Llc1996-03-13INDINAVIR SULFATEORALCAPSULE000060573NDA02068583aeddf8-6fed-487c-858b-2240f0a0e8af
2216950366CrixivanNDARebel Distributors Corp1996-03-13INDINAVIR SULFATEORALCAPSULE000060573NDA02068501c5574c-1056-49c6-af20-e950db3f4139
3538080661CrixivanNDAState Of Florida Doh Central Pharmacy2009-07-01INDINAVIR SULFATEORALCAPSULE000060573NDA020685702727cb-3eff-425b-9573-031332849430
4691890574CrixivanNDAAvera Mckennan Hospital2015-03-01INDINAVIR SULFATEORALCAPSULE000060573NDA0206858ead8c87-f5c3-4aba-bb99-1bc29e2f1551

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA020685CRIXIVANMERCK SHARP AND DOHME CORP1996-03-13p6689761, TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS
p6645961, SUBSTANCE
NDA020685_001, NDA020685_003, NDA020685_005, NDA020685_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020685_001RXINDINAVIR SULFATE (EQ 400MG BASE)ORALCAPSULETrue1996-03-13CRIXIVAN
2NDA020685_003RXINDINAVIR SULFATE (EQ 200MG BASE)ORALCAPSULEFalse1996-03-13CRIXIVAN
3NDA020685_005discontinuedINDINAVIR SULFATE (EQ 333MG BASE)ORALCAPSULEFalse1998-12-17CRIXIVAN
4NDA020685_006discontinuedINDINAVIR SULFATE (EQ 100MG BASE)ORALCAPSULEFalse2000-04-19CRIXIVAN

patent(s)

#idexpiration dateapplication(s)
1p6645961 (view patent)2018-03-04NDA020685
2p6689761 (view patent)2021-02-10NDA020685

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101c5574c-1056-49c6-af20-e950db3f4139 (view SPL)CRIXIVAN (INDINAVIR SULFATE)CAPSULESprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-241216950366
2702727cb-3eff-425b-9573-031332849430 (view SPL)CRIXIVAN (INDINAVIR SULFATE)CAPSULESprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-08-183538080661
383aeddf8-6fed-487c-858b-2240f0a0e8af (view SPL)CRIXIVAN (INDINAVIR SULFATE)CAPSULESprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-06-141165900064
48ead8c87-f5c3-4aba-bb99-1bc29e2f1551 (view SPL)CRIXIVAN (INDINAVIR SULFATE)CAPSULESprescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-11-171691890574
5e19405d9-d9a1-4072-5b9e-40cd3ae4bf1f (view SPL)CRIXIVAN (INDINAVIR SULFATE)CAPSULESprescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE2015-03-2721000060571, 000060573, 000060570

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