polyethylene glycols
titanium dioxide
polysorbate 80
sodium chloride
butylated hydroxytoluene
Product Characteristics
Color GRAY Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 15;XL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-815-01 100 TABLET, EXTENDED RELEASE ( TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020897 06/26/1999
Labeler - Janssen Pharmaceuticals, Inc. (063137772)
Establishment
Name Address ID/FEI Operations
PCAS France (API) 396133998 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
ALZA Corporation (Product) 175417641 MANUFACTURE, ANALYSIS
Revised: 12/2011 Janssen Pharmaceuticals, Inc.
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