Oseltamivir Oral Suspension

Brand(s)
Tamiflu
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2014-12-01)
Oldest Current Product
2000-12-14
License(s)
NDA
RxNORM
ORAL SUSPENSION\OSELTAMIVIR
FDAOB
ORAL\FOR SUSPENSION\OSELTAMIVIR PHOSPHATE
SPL Active
ORAL\POWDER, FOR SUSPENSION\OSELTAMIVIR PHOSPHATE
SPL Moiety
ORAL\POWDER, FOR SUSPENSION\OSELTAMIVIR
ORAL\POWDER, FOR SUSPENSION\OSELTAMIVIR ACID

product(s) by strength(s)

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1550453198TamifluNDADispensing Solutions, Inc.2000-12-14OSELTAMIVIR PHOSPHATEORALPOWDER, FOR SUSPENSION000040810NDA021246ca868d3d-177d-42c4-b05b-7beae7343b53

oseltamivir 6 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000040820TamifluNDAGenentech, Inc.2011-07-112014-09-30OSELTAMIVIR PHOSPHATEORALPOWDER, FOR SUSPENSIONNDA021246ee3c9555-60f2-4f82-a760-11983c86e97b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540092TamifluNDARebel Distributors Corp2011-07-11OSELTAMIVIR PHOSPHATEORALPOWDER, FOR SUSPENSION000040820NDA02124603a2a7f0-406c-4784-84c1-5fd5f5be4773
2548686315TamifluNDAPhysicians Total Care, Inc.2011-11-03OSELTAMIVIR PHOSPHATEORALPOWDER, FOR SUSPENSION000040820NDA0212461948cafd-b5b3-4212-9d5d-8c293b1baad5

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA021246TAMIFLUHOFFMANN LA ROCHE INC2000-12-14p5763483, TREATMENT AND PROPHYLAXIS OF INFLUENZA/ TREATMENT OF INFLUENZA, SUBSTANCE
p5866601, SUBSTANCE
p5952375, SUBSTANCE
NEW PATIENT POPULATION [2015-12-21]NDA021246_001, NDA021246_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021246_001discontinuedOSELTAMIVIR PHOSPHATE (EQ 12MG BASE/ML)ORALFOR SUSPENSIONFalse2000-12-14TAMIFLU
2NDA021246_002RXOSELTAMIVIR PHOSPHATE (EQ 6MG BASE/ML)ORALFOR SUSPENSIONTrue2011-03-21TAMIFLU

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5763483 (view patent)2016-08-23NDA021246, NDA021087Oseltamivir Oral Capsule
2p5866601 (view patent)2016-02-02NDA021246, NDA021087Oseltamivir Oral Capsule
3p5952375 (view patent)2015-02-27NDA021246, NDA021087Oseltamivir Oral Capsule

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
103a2a7f0-406c-4784-84c1-5fd5f5be4773 (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 PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-271422540092
21948cafd-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.relabel2011-12-222548686315, 548684476, 548686083Oseltamivir Oral Capsule
3ca868d3d-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, repack2011-10-051550453198, 550452759Oseltamivir Oral Capsule
4ee3c9555-60f2-4f82-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, PACK2014-12-0130000040820, 000040800, 000040801, 000040802, 000040822Oseltamivir Oral Capsule

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