starch glycolate type A potato (UNII: 5856J3G2A2)
sodium stearyl fumarate (UNII: 7CV7WJK4UI)
titanium dioxide (UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
propylene glycol (UNII: 6DC9Q167V3)
FD&C Blue No. 2 (UNII: L06K8R7DQK)
carnauba wax (UNII: R12CBM0EIZ)
PRODUCT CHARACTERISTICS
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code A
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50458-210-01 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 05/07/2001
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021001 05/07/2001
LABELER - JANSSEN PHARMACEUTICALS, INC. (063137772)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Janssen-Ortho LLC 805887986 ANALYSIS(50458-211, 50458-210) , MANUFACTURE(50458-211, 50458-210)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Ranke Quimica, S.L. 563076157 API MANUFACTURE(50458-211, 50458-210) |
