efavirenz Oral Capsule

Brand(s)
Sustiva
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bristol-Myers Squibb Pharma Company (2015-03-27)
Oldest Current Product
1998-09-17
License(s)
NDA
RxNORM
ORAL CAPSULE\EFAVIRENZ
FDAOB
ORAL\CAPSULE\EFAVIRENZ
SPL Active
ORAL\CAPSULE, GELATIN COATED\EFAVIRENZ
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\EFAVIRENZ

product(s) by strength(s)

efavirenz 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000560474SustivaNDABristol-Myers Squibb Pharma Company1998-09-17EFAVIRENZORALCAPSULE, GELATIN COATEDNDA02097232d6371e-ba56-4294-b732-6d43627c5c47

efavirenz 50 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000560470SustivaNDABristol-Myers Squibb Pharma Company1998-09-17EFAVIRENZORALCAPSULE, GELATIN COATEDNDA02097232d6371e-ba56-4294-b732-6d43627c5c47

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA020972SUSTIVABRISTOL MYERS SQUIBB CO1998-09-17p6555133, TREATMENT OF HIV
p5663169, TREATMENT OF HIV INFECTION
p6639071
p6939964
p6238695, SUBSTANCE
NEW PATIENT POPULATION [2016-05-02]
PEDIATRIC EXCLUSIVITY [2016-11-02]
NDA020972_001, NDA020972_002, NDA020972_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020972_001RXEFAVIRENZ (50MG)ORALCAPSULEFalse1998-09-17SUSTIVA
2NDA020972_002discontinuedEFAVIRENZ (100MG)ORALCAPSULEFalse1998-09-17SUSTIVA
3NDA020972_003RXEFAVIRENZ (200MG)ORALCAPSULETrue1998-09-17SUSTIVA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5663169 (view patent)2014-09-02NDA020972, NDA021360, NDA021937efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
efavirenz Oral Tablet
2p6238695 (view patent)2019-04-06NDA020972
3p6555133 (view patent)2019-04-06NDA020972
4p6639071 (view patent)2018-02-14NDA020972, NDA021360, NDA021937efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
efavirenz Oral Tablet
5p6939964 (view patent)2018-01-20NDA020972, NDA021360, NDA021937efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
efavirenz Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
132d6371e-ba56-4294-b732-6d43627c5c47 (view SPL)These highlights do not include all the information needed to use SUSTIVA safely and effectively. See full prescribing information for SUSTIVA. SUSTIVA (efavirenz) capsules for oral useSUSTIVA (efavirenz) tablets for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionBristol-Myers Squibb Pharma Company2015-03-2724000560470, 000560474, 000560510efavirenz Oral Tablet

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