Clonazepam (Page 7 of 7)

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CLONAZEPAM clonazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-0136(NDC:16729-136)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM (CLONAZEPAM) CLONAZEPAM 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
FD&C YELLOW NO. 6
Product Characteristics
Color Orange Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 1;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64725-0136-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077147 11/24/2010
Labeler — TYA Pharmaceuticals (938389038)
Registrant — TYA Pharmaceuticals (938389038)
Establishment
Name Address ID/FEI Operations
TYA Pharmaceuticals 938389038 RELABEL (64725-0136), REPACK (64725-0136)

Revised: 11/2010 TYA Pharmaceuticals

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