felbamate Oral Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Wallace Pharmaceuticals Inc. (2011-11-23)
Oldest Current Product
2011-11-23
License(s)
NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SUSPENSION\FELBAMATE
FDAOB
ORAL\SUSPENSION\FELBAMATE
ORAL\TABLET\FELBAMATE
SPL Active
ORAL\SUSPENSION\FELBAMATE
SPL Moiety
ORAL\SUSPENSION\FELBAMATE

product(s) by strength(s)

felbamate 120 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1515250442NDA AUTHORIZED GENERICWallace Pharmaceuticals Inc.2011-11-23FELBAMATEORALSUSPENSIONNDA020189c0c15d60-1171-11e1-9be0-0002a5d5c51b
2651620686ANDAAmneal Pharmaceuticals2011-12-16FELBAMATEORALSUSPENSIONANDA2023852e325d79-d0a4-4af7-b09b-96ee5a5b2a37

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA201680FELBAMATEAMNEAL PHARMACEUTICALS2011-09-13ANDA201680_001, ANDA201680_002felbamate Oral Tablet
2ANDA202284FELBAMATECOREPHARMA LLC2015-11-04ANDA202284_001, ANDA202284_002felbamate Oral Tablet
3ANDA202385FELBAMATEAMNEAL PHARMACEUTICALS2011-12-16ANDA202385_001felbamate Oral Tablet
4NDA020189FELBATOLMEDA PHARMACEUTICALS INC1993-07-29NDA020189_001, NDA020189_002, NDA020189_003felbamate Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201680_001RXFELBAMATE (400MG)ORALTABLETFalseAB2011-09-13FELBAMATE
2ANDA201680_002RXFELBAMATE (600MG)ORALTABLETFalseAB2011-09-13FELBAMATE
3ANDA202284_001RXFELBAMATE (400MG)ORALTABLETFalseAB2015-11-04FELBAMATE
4ANDA202284_002RXFELBAMATE (600MG)ORALTABLETFalseAB2015-11-04FELBAMATE
5ANDA202385_001RXFELBAMATE (600MG/5ML)ORALSUSPENSIONFalseAB2011-12-16FELBAMATE
6NDA020189_001RXFELBAMATE (400MG)ORALTABLETFalseAB1993-07-29FELBATOL
7NDA020189_002RXFELBAMATE (600MG)ORALTABLETTrueAB1993-07-29FELBATOL
8NDA020189_003RXFELBAMATE (600MG/5ML)ORALSUSPENSIONTrueAB1993-07-29FELBATOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
12e325d79-d0a4-4af7-b09b-96ee5a5b2a37 (view SPL)Felbamate Oral Suspension 600 mg/5 mLRx OnlyprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-02-206651620686
2c0c15d60-1171-11e1-9be0-0002a5d5c51b (view SPL)Felbamate Tablets 400 mg and 600 mg, Oral Suspension 600 mg/5 mL IIN-0321-02Rev. 9/11 Before Prescribing Felbamate the physician should be thoroughly familiar with the details of this prescribing information. FELBAMATE SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND THE PATIENT, PARENT, OR GUARDIAN HAS BEEN PROVIDED THE FELBAMATE WRITTEN ACKNOWLEDGEMENT (SEE PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM).prescriptionHuman PrescriptionWallace Pharmaceuticals Inc.2011-11-232515250442, 515250430, 515250431felbamate Oral Tablet

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