Abacavir (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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ABACAVIR abacavir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-717
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ABACAVIR SULFATE (ABACAVIR) ABACAVIR 300
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE B POTATO
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Dark) Score 2 pieces
Shape CAPSULE (Biconvex) Size 18mm
Flavor Imprint Code AB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-717-03 60 TABLET in 1 BOTTLE None
2 NDC:64380-717-01 60 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091050 10/28/2016
Labeler — Strides Shasun Limited (650738743)
Registrant — Strides Shasun Limited (650738743)
Establishment
Name Address ID/FEI Operations
Strides Shasun Limited 918513263 ANALYSIS (64380-717), MANUFACTURE (64380-717), PACK (64380-717)

Revised: 01/2017 Strides Shasun Limited

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