REFISSA
Approved
Approval ID
ac92dfd3-6517-43d0-b6c1-b86fdf3a761f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2014
Manufacturers
FDA
Suneva Medical, Inc.
DUNS: 012844615
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRETINOIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50224-002
Application NumberANDA076498
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRETINOIN
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 8, 2014
FDA Product Classification
INGREDIENTS (10)
TRETINOINActive
Quantity: 0.5 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT