G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PRODUCT CHARACTERISTICS
Color YELLOW (Light Yellow) Score no score
Shape CAPSULE (Biconvex) Size 16mm
Flavor Imprint Code I90
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-922-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2017
2 NDC:65862-922-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2017
3 NDC:65862-922-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2017
4 NDC:65862-922-99 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2017
5 NDC:65862-922-78 10 in 1 CARTON 03/22/2017
5 NDC:65862-922-10 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207152 03/22/2017
LABELER - AUROBINDO PHARMA LIMITED (650082092)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 650381903 ANALYSIS(65862-922) , MANUFACTURE(65862-922)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917626 API MANUFACTURE(65862-922)
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