Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8)
Zydus Lifesciences Limited
FELBAMATE
FELBAMATE 400 mg
ORAL
PRESCRIPTION DRUG
Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children. Felbamate is contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history of any blood dyscrasia or hepa
Felbamate Tablets USP, 400 mg are off-white to pale yellow colored, capsule shaped biconvex tablets, debossed with "10" and "53" separated by breakline on one side and plain on other and are supplied as: NDC 70771-1077-3 in bottles of 30 tablets NDC 70771-1077-9 in bottles of 90 tablets NDC 70771-1077-1 in bottles of 100 tablets NDC 70771-1077-5 in bottles of 500 tablets NDC 70771-1077-4 in cartons of 100 tablets (10 x 10 unit-dose) Felbamate Tablets USP, 600 mg are light pink to pink colored, capsule shaped biconvex tablets debossed with "10" and "54" separated by breakline on one side and plain on other and are supplied as: NDC 70771-1078-3 in bottles of 30 tablets NDC 70771-1078-9 in bottles of 90 tablets NDC 70771-1078-1 in bottles of 100 tablets NDC 70771-1078-8 in bottles of 180 tablets NDC 70771-1078-5 in bottles of 500 tablets NDC 70771-1078-4 in cartons of 100 tablets (10 x 10 unit-dose) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. Manufactured by: Cadila Healthcare Limited Matoda, Ahmedabad, India. Rev.: 06/17
Abbreviated New Drug Application
Zydus Lifesciences Limited ---------- SPL MEDGUIDE Revised: 10/2023 Document Id: 8ed3eb6a-7697-400c-ae6f-ff5387b71e0c 34391-3 Set id: efa55cb2-b625-4392-9ddb-0a8ad8ee58c4 Version: 5 Effective Time: 20231004 Zydus Lifesciences Limited Lesen Sie das vollständige Dokument
FELBAMATE- FELBAMATE TABLET ZYDUS LIFESCIENCES LIMITED ---------- FELBAMATE TABLETS, USP SPL MEDGUIDE PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1077-1 Felbamate tablets USP, 400 mg 100 Tablets Rx only NDC 70771-1078-1 Felbamate tablets USP, 600 mg 100 Tablets Rx only FELBAMATE felbamate tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1077 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8) FELBAMATE 400 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ALUMINUM OXIDE (UNII: LMI26O6933) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C RED NO. 40 (UNII: WZB9127XOA) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) PRODUCT CHARACTERISTICS COLOR WHITE (OFF-WHITE TO PALE YELLOW COLOR) SCORE 2 pieces SHAPE CAPSULE (CAPSULE) SIZE 16mm FLAVOR IMPRINT CODE 10;53 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1077-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 2 NDC:70771- 1077-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 3 NDC:70771- 1077-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 4 NDC:70771- 1077-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 5 NDC:70771- 1077-4 10 in 1 CARTON 08/15/2017 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA208970 08/15/2017 FELBAMATE felbamate tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1078 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH FELBAM Lesen Sie das vollständige Dokument