felbamate Oral Tablet

Brand(s)
Felbatol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Meda Pharmaceuticals Inc. (2011-11-14)
Oldest Current Product
1993-07-29
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\FELBAMATE
FDAOB
ORAL\SUSPENSION\FELBAMATE
ORAL\TABLET\FELBAMATE
SPL Active
ORAL\TABLET\FELBAMATE
SPL Moiety
ORAL\TABLET\FELBAMATE

product(s) by strength(s)

felbamate 400 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000370430FelbatolNDAMeda Pharmaceuticals Inc.1993-07-29FELBAMATEORALTABLETNDA0201892f522701-397a-11de-8a39-0800200c9a66

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101350601ANDAMarlex Pharmaceuticals Inc2015-08-01FELBAMATEORALTABLETANDA2016800a82bcc3-0420-45f5-8c5c-44ab378b4ff3
2515250430NDA AUTHORIZED GENERICWallace Pharmaceuticals Inc.2011-11-11FELBAMATEORALTABLETNDA020189c0c15d60-1171-11e1-9be0-0002a5d5c51b
3651620734ANDAAmneal Pharmaceuticals2011-09-16FELBAMATEORALTABLETANDA201680aa3fd2c0-98d6-45f3-81b0-a902526214c6

felbamate 600 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101350602ANDAMarlex Pharmaceuticals Inc2015-08-01FELBAMATEORALTABLETANDA2016800a82bcc3-0420-45f5-8c5c-44ab378b4ff3
2515250431NDA AUTHORIZED GENERICWallace Pharmaceuticals Inc.2011-11-11FELBAMATEORALTABLETNDA020189c0c15d60-1171-11e1-9be0-0002a5d5c51b
3651620735ANDAAmneal Pharmaceuticals2011-09-16FELBAMATEORALTABLETANDA201680aa3fd2c0-98d6-45f3-81b0-a902526214c6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681514474ANDACarilion Materials Management2011-09-16FELBAMATEORALTABLET651620735ANDA201680ce919497-c2f3-4362-bfb7-cf4e82e10a5c

application(s)

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

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
10a82bcc3-0420-45f5-8c5c-44ab378b4ff3 (view SPL)Felbamate TabletsprescriptionHuman PrescriptionMarlex Pharmaceuticals Inc2015-08-011101350601, 101350602
22f522701-397a-11de-8a39-0800200c9a66 (view SPL)FELBATOL (felbamate) Tablets 400 mg and 600 mg, Oral Suspension 600 mg/5 mL IN-00431-18Rev. 7/11 Before Prescribing Felbatol (felbamate), the physician should be thoroughly familiar with the details of this prescribing information. FELBATOL 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 FELBATOL WRITTEN ACKNOWLEDGEMENT (SEE PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM).prescriptionHuman PrescriptionMeda Pharmaceuticals Inc.2011-11-145000370430
3aa3fd2c0-98d6-45f3-81b0-a902526214c6 (view SPL)FELBAMATE TABLETSprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK, REPACK2015-06-096651620734, 651620735
4c0c15d60-1171-11e1-9be0-0002a5d5c51b (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.2011-11-232515250430, 515250431, 515250442felbamate Oral Suspension
5ce919497-c2f3-4362-bfb7-cf4e82e10a5c (view SPL)FELBAMATE TABLETSprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-09-202681514474

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