NDC 53746-735

Felbamate

Felbamate

Felbamate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Felbamate.

Product ID53746-735_d3294e06-4a9b-4bf5-9e23-2a512bbb273f
NDC53746-735
Product TypeHuman Prescription Drug
Proprietary NameFelbamate
Generic NameFelbamate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-08-10
Marketing CategoryANDA /
Application NumberANDA201680
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameFELBAMATE
Active Ingredient Strength600 mg/1
Pharm ClassesAnti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 53746-735-18

180 TABLET in 1 BOTTLE (53746-735-18)
Marketing Start Date2022-08-10
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Felbamate" or generic name "Felbamate"

NDCBrand NameGeneric Name
0115-1746FelbamateFelbamate
0115-1747FelbamateFelbamate
0121-0891FelbamateFelbamate
10135-601FelbamateFelbamate
10135-602FelbamateFelbamate
16714-775FelbamateFelbamate
47781-550Felbamatefelbamate
47781-551Felbamatefelbamate
47781-627Felbamatefelbamate
47781-630Felbamatefelbamate
51525-0430Felbamatefelbamate
51525-0431Felbamatefelbamate
51525-0442Felbamatefelbamate
51672-4172FelbamateFelbamate
51672-4185FelbamateFelbamate
51672-4186FelbamateFelbamate
53746-734FelbamateFelbamate
53746-735FelbamateFelbamate
68151-4474FelbamateFelbamate
70710-1054FelbamateFelbamate
70710-1053FelbamateFelbamate
70771-1078FelbamateFelbamate
70771-1077FelbamateFelbamate
62559-731FelbamateFelbamate
62559-730FelbamateFelbamate
64720-256FelbamateFelbamate
65162-734FelbamateFelbamate
65162-686FelbamateFelbamate
65162-735FelbamateFelbamate
66689-825FelbamateFelbamate
72578-056FelbamateFelbamate
72578-057FelbamateFelbamate
63629-1944FelbamateFelbamate
63629-1937FelbamateFelbamate
0037-0430Felbatolfelbamate
0037-0431Felbatolfelbamate
0037-0442Felbatolfelbamate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.