Basic Information
Isotretinoin
57664-025
Regulatory Information
57664-025
NDA021951
C73605
January 10, 2024
USA
These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982
HUMAN PRESCRIPTION DRUG LABEL
2
Company Information
146974886
Active Ingredients
Inactive Ingredients
PROPYL GALLATE
Code: 8D4SNN7V92
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
SOYBEAN OIL
Code: 241ATL177A
Class Code: IACT
SORBITAN MONOOLEATE
Code: 06XEA2VD56
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
SODIUM HYDROXIDE
Code: 55X04QC32I
Class Code: IACT
PEG-32 HYDROGENATED PALM GLYCERIDES
Code: G6EP177239
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
Active Moieties
ISOTRETINOIN
Code: EH28UP18IF