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)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 515250442 | NDA AUTHORIZED GENERIC | Wallace Pharmaceuticals Inc. | 2011-11-23 | FELBAMATE | ORAL | SUSPENSION | NDA020189 | c0c15d60-1171-11e1-9be0-0002a5d5c51b |
| 2 | 651620686 | ANDA | Amneal Pharmaceuticals | 2011-12-16 | FELBAMATE | ORAL | SUSPENSION | ANDA202385 | 2e325d79-d0a4-4af7-b09b-96ee5a5b2a37 |
application(s)
| # | id | title | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|
| 1 | ANDA201680 | FELBAMATE | AMNEAL PHARMACEUTICALS | 2011-09-13 | ANDA201680_001, ANDA201680_002 | felbamate Oral Tablet |
| 2 | ANDA202284 | FELBAMATE | COREPHARMA LLC | 2015-11-04 | ANDA202284_001, ANDA202284_002 | felbamate Oral Tablet |
| 3 | ANDA202385 | FELBAMATE | AMNEAL PHARMACEUTICALS | 2011-12-16 | ANDA202385_001 | felbamate Oral Tablet |
| 4 | NDA020189 | FELBATOL | MEDA PHARMACEUTICALS INC | 1993-07-29 | NDA020189_001, NDA020189_002, NDA020189_003 | felbamate Oral Tablet |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA201680_001 | RX | FELBAMATE (400MG) | ORAL | TABLET | False | AB | 2011-09-13 | FELBAMATE |
| 2 | ANDA201680_002 | RX | FELBAMATE (600MG) | ORAL | TABLET | False | AB | 2011-09-13 | FELBAMATE |
| 3 | ANDA202284_001 | RX | FELBAMATE (400MG) | ORAL | TABLET | False | AB | 2015-11-04 | FELBAMATE |
| 4 | ANDA202284_002 | RX | FELBAMATE (600MG) | ORAL | TABLET | False | AB | 2015-11-04 | FELBAMATE |
| 5 | ANDA202385_001 | RX | FELBAMATE (600MG/5ML) | ORAL | SUSPENSION | False | AB | 2011-12-16 | FELBAMATE |
| 6 | NDA020189_001 | RX | FELBAMATE (400MG) | ORAL | TABLET | False | AB | 1993-07-29 | FELBATOL |
| 7 | NDA020189_002 | RX | FELBAMATE (600MG) | ORAL | TABLET | True | AB | 1993-07-29 | FELBATOL |
| 8 | NDA020189_003 | RX | FELBAMATE (600MG/5ML) | ORAL | SUSPENSION | True | AB | 1993-07-29 | FELBATOL |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2e325d79-d0a4-4af7-b09b-96ee5a5b2a37 (view SPL) | Felbamate Oral Suspension 600 mg/5 mLRx Only | prescription | Human Prescription | Amneal Pharmaceuticals | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-02-20 | 6 | 651620686 | |
| 2 | c0c15d60-1171-11e1-9be0-0002a5d5c51b (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). | prescription | Human Prescription | Wallace Pharmaceuticals Inc. | 2011-11-23 | 2 | 515250442, 515250430, 515250431 | felbamate Oral Tablet |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII