raph Citation Marketing Start Date Marketing End Date
NDA NDA022399 05/01/2013
HORIZANT
gabapentin enacarbil tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53451-0101
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN ENACARBIL (UNII: 75OCL1SPBQ) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN ENACARBIL 600 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) 518.2 mg
TALC (UNII: 7SEV7J4R1U) 80.0 mg
GLYCERYL BEHENATE (UNII: R8WTH25YS2) 60.1 mg
MAGNESIUM STEARATE (UNII: 70097M6I30) 22.3 mg
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 24.0 mg
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 5.4 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code GS;LFG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53451-0101-1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2 NDC:53451-0101-9 5 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022399 05/01/2013
Labeler - XenoPort Inc. (128874083)
Establishment
Name Address ID/FEI Business Operations
Patheon Pharmaceuticals, Inc. 005286822 ANALYSIS(53451-0103, 53451-0101) , LABEL(53451-0103, 53451-0101) , MANUFACTURE(53451-0103, 53451-0101
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