Oseltamivir Oral Capsule

Brand(s)
Tamiflu
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2014-12-01)
Oldest Current Product
1999-10-27
License(s)
NDA
RxNORM
ORAL CAPSULE\OSELTAMIVIR
FDAOB
ORAL\CAPSULE\OSELTAMIVIR PHOSPHATE
SPL Active
ORAL\CAPSULE\OSELTAMIVIR PHOSPHATE
SPL Moiety
ORAL\CAPSULE\OSELTAMIVIR
ORAL\CAPSULE\OSELTAMIVIR ACID

product(s) by strength(s)

oseltamivir 30 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040802TamifluNDAGenentech, Inc.1999-10-27OSELTAMIVIR PHOSPHATEORALCAPSULENDA021087ee3c9555-60f2-4f82-a760-11983c86e97b

oseltamivir 45 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040801TamifluNDAGenentech, Inc.1999-10-27OSELTAMIVIR PHOSPHATEORALCAPSULENDA021087ee3c9555-60f2-4f82-a760-11983c86e97b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686083TamifluNDAPhysicians Total Care, Inc.2009-10-30OSELTAMIVIR PHOSPHATEORALCAPSULE000040801NDA0210871948cafd-b5b3-4212-9d5d-8c293b1baad5

oseltamivir 75 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040800TamifluNDAGenentech, Inc.1999-10-27OSELTAMIVIR PHOSPHATEORALCAPSULENDA021087ee3c9555-60f2-4f82-a760-11983c86e97b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540001TamifluNDARebel Distributors Corp1999-10-27OSELTAMIVIR PHOSPHATEORALCAPSULE000040800NDA021087644ddc43-b2fa-44bd-aeb7-2547defb85e0
2521250307TamifluNDARemedyrepack Inc.2013-05-13OSELTAMIVIR PHOSPHATEORALCAPSULE000040800NDA0210872f912317-c0de-445a-8729-a99a8d2acaad
3548684476TamifluNDAPhysicians Total Care, Inc.2002-10-28OSELTAMIVIR PHOSPHATEORALCAPSULE000040800NDA0210871948cafd-b5b3-4212-9d5d-8c293b1baad5
4550452759TamifluNDADispensing Solutions, Inc.1999-10-27OSELTAMIVIR PHOSPHATEORALCAPSULE000040800NDA021087ca868d3d-177d-42c4-b05b-7beae7343b53

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA021087TAMIFLUHOFFMANN LA ROCHE INC1999-10-27p5763483, TREATMENT AND PROPHYLAXIS OF INFLUENZA, SUBSTANCE
p5866601, SUBSTANCE
p5952375, SUBSTANCE
NEW PATIENT POPULATION [2015-12-21]NDA021087_001, NDA021087_002, NDA021087_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021087_001RXOSELTAMIVIR PHOSPHATE (EQ 75MG BASE)ORALCAPSULETrue1999-10-27TAMIFLU
2NDA021087_002RXOSELTAMIVIR PHOSPHATE (EQ 45MG BASE)ORALCAPSULEFalse2007-07-02TAMIFLU
3NDA021087_003RXOSELTAMIVIR PHOSPHATE (EQ 30MG BASE)ORALCAPSULEFalse2007-07-02TAMIFLU

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5763483 (view patent)2016-08-23NDA021087, NDA021246Oseltamivir Oral Suspension
2p5866601 (view patent)2016-02-02NDA021087, NDA021246Oseltamivir Oral Suspension
3p5952375 (view patent)2015-02-27NDA021087, NDA021246Oseltamivir Oral Suspension

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11948cafd-b5b3-4212-9d5d-8c293b1baad5 (view SPL)These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU (oseltamivir phosphate) capsules TAMIFLU (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-12-222548684476, 548686083, 548686315Oseltamivir Oral Suspension
22f912317-c0de-445a-8729-a99a8d2acaad (view SPL)These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU (oseltamivir phosphate) capsules, for oral use TAMIFLU (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-131521250307
3644ddc43-b2fa-44bd-aeb7-2547defb85e0 (view SPL)These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU (oseltamivir phosphate) capsules Initial U.S. Approval: 1999prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-11-021422540001
4ca868d3d-177d-42c4-b05b-7beae7343b53 (view SPL)These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU (oseltamivir phosphate) capsules TAMIFLU (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-10-051550452759, 550453198Oseltamivir Oral Suspension
5ee3c9555-60f2-4f82-a760-11983c86e97b (view SPL)These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU (oseltamivir phosphate) capsules, for oral use TAMIFLU (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-12-0130000040800, 000040801, 000040802, 000040820, 000040822Oseltamivir Oral Suspension

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