Epuris
Approved
Approval ID
06c2459c-ff0f-6f53-e063-6394a90a518a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2023
Manufacturers
FDA
Galephar Pharmaceutical Research Inc.
DUNS: 003551624
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66277-336
Product Classification
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (5)
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
ISOTRETINOINActive
Quantity: 10 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
Isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66277-335
Product Classification
G
Generic Name
Isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (5)
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
PEG-32 HYDROGENATED PALM GLYCERIDESInactive
Code: G6EP177239
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
ISOTRETINOINActive
Quantity: 20 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT