Basic Information
Dutasteride
59651-021
Regulatory Information
59651-021
ANDA202660
C73584
January 3, 2023
USA
These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules for oral use Initial U.S. Approval: 2001
Human Prescription Drug Label
1
Company Information
650082092
Active Ingredients
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATE
Code: U72Q2I8C85
Class Code: IACT
BUTYLATED HYDROXYTOLUENE
Code: 1P9D0Z171K
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
GLYCERIN
Code: PDC6A3C0OX
Class Code: IACT
MEDIUM-CHAIN TRIGLYCERIDES
Code: C9H2L21V7U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
LECITHIN, SOYBEAN
Code: 1DI56QDM62
Class Code: IACT
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
DIMETHICONE
Code: 92RU3N3Y1O
Class Code: IACT
Active Moieties
DUTASTERIDE
Code: O0J6XJN02I