Riluzole Oral Tablet

Brand(s)
Rilutek
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Rising Pharmaceuticals, Inc. (2013-05-24)
Oldest Current Product
1995-12-12
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\RILUZOLE
FDAOB
ORAL\TABLET\RILUZOLE
SPL Active
ORAL\TABLET, FILM COATED\RILUZOLE
ORAL\TABLET\RILUZOLE
SPL Moiety
ORAL\TABLET, FILM COATED\RILUZOLE
ORAL\TABLET\RILUZOLE

product(s) by strength(s)

riluzole 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000757700RilutekNDASanofi-Aventis U.S. Llc1995-12-12RILUZOLEORALTABLET, FILM COATEDNDA020599e49d207d-8e32-4183-94ba-cd264f124090

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001153000ANDAGlobal Pharmaceuticals2003-01-29RILUZOLEORALTABLET, FILM COATEDANDA076173ace12152-117c-455b-8e68-e6325657569e
2003784145ANDAMylan Pharmaceuticals Inc.2013-07-22RILUZOLEORALTABLET, FILM COATEDANDA20304297457622-5727-4b07-9e72-edd784b2d76d
3605053285ANDAApotex Corp2013-06-18RILUZOLEORALTABLET, FILM COATEDANDA091300ba1f7351-76cd-a872-c9e0-57db929e84de
4627560538ANDASun Pharmaceutical Industries Limited2013-06-18RILUZOLEORALTABLET, FILM COATEDANDA0914174c851be4-f0d0-4b24-baf9-427ddfc6f7b0
5649800191NDA AUTHORIZED GENERICRising Pharmaceuticals, Inc.2013-05-15RILUZOLEORALTABLET, FILM COATEDNDA020599f3c2360d-cec4-4a4a-83b6-35e0114d2bc3
6684620381ANDAGlenmark Generics Inc., Usa2013-06-18RILUZOLEORALTABLET, FILM COATEDANDA091394f1ce57e8-d3fe-422c-8724-3101c258898a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790143RilutekNDAKaiser Foundations Hospitals2014-01-20RILUZOLEORALTABLET249870700NDA0205998c385278-59f8-4a2f-abf1-dc44c6014b87
2001790150ANDAKaiser Foundations Hospitals2014-05-14RILUZOLEORALTABLET, FILM COATED627560538ANDA0914171e751a55-f807-48c7-ab4b-ec8d42770bb9
3422910723NDA AUTHORIZED GENERICAvkare, Inc.2014-01-08RILUZOLEORALTABLET, FILM COATED649800191NDA0205992afbb5d6-6fca-88cd-d627-2d748141b677
4680840908ANDAAmerican Health Packaging2015-03-31RILUZOLEORALTABLET, FILM COATED605053285ANDA09130062719a26-880c-48ce-81dc-a9228e9cc0d7

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076173RILUZOLEIMPAX LABORATORIES INC2003-01-29ANDA076173_001
2ANDA091300RILUZOLEAPOTEX CORP2013-06-18ANDA091300_001
3ANDA091394RILUZOLEGLENMARK GENERICS LTD2013-06-18ANDA091394_001
4ANDA091417RILUZOLESUN PHARMACEUTICAL INDUSTRIES LTD2013-06-18ANDA091417_001
5ANDA203042RILUZOLEMYLAN PHARMACEUTICALS INC2013-07-01ANDA203042_001
6NDA020599RILUTEKCOVIS PHARMA SARL1995-12-12NDA020599_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076173_001RXRILUZOLE (50MG)ORALTABLETFalseAB2003-01-29RILUZOLE
2ANDA091300_001RXRILUZOLE (50MG)ORALTABLETFalseAB2013-06-18RILUZOLE
3ANDA091394_001RXRILUZOLE (50MG)ORALTABLETFalseAB2013-06-18RILUZOLE
4ANDA091417_001RXRILUZOLE (50MG)ORALTABLETFalseAB2013-06-18RILUZOLE
5ANDA203042_001RXRILUZOLE (50MG)ORALTABLETFalseAB2013-07-01RILUZOLE
6NDA020599_001RXRILUZOLE (50MG)ORALTABLETTrueAB1995-12-12RILUTEK

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
110c8d5e6-cb9f-402d-ab8e-65c1aa049e89 (view SPL)RILUTEK (riluzole) TabletsprescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2013-07-101249870700
21e751a55-f807-48c7-ab4b-ec8d42770bb9 (view SPL)Riluzole Tablets, USPprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2014-05-191001790150
32afbb5d6-6fca-88cd-d627-2d748141b677 (view SPL)Riluzole TabletsprescriptionHuman PrescriptionAvkare, Inc.2014-01-081422910723
44c851be4-f0d0-4b24-baf9-427ddfc6f7b0 (view SPL)Riluzole Tablets, USPprescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-116627560538
562719a26-880c-48ce-81dc-a9228e9cc0d7 (view SPL)RILUZOLE TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-152680840908
68c385278-59f8-4a2f-abf1-dc44c6014b87 (view SPL)RILUTEK (riluzole) TabletsprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2014-01-221001790143
797457622-5727-4b07-9e72-edd784b2d76d (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-12-312003784145
8ace12152-117c-455b-8e68-e6325657569e (view SPL)RILUZOLE TABLETS, 50 MGprescriptionHuman PrescriptionGlobal Pharmaceuticals2013-05-242001153000
9ba1f7351-76cd-a872-c9e0-57db929e84de (view SPL)Riluzole Tablets 50 mgprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2013-05-082605053285
10e49d207d-8e32-4183-94ba-cd264f124090 (view SPL)RILUTEK (riluzole) TabletsprescriptionHuman PrescriptionSanofi-Aventis U.S. LlcMANUFACTURE2012-11-207000757700
11f1ce57e8-d3fe-422c-8724-3101c258898a (view SPL)Riluzole Tablets USP, 50 mgprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2013-06-205684620381
12f3c2360d-cec4-4a4a-83b6-35e0114d2bc3 (view SPL)Riluzole TabletsprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.2013-05-244649800191

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