ACITRETIN
Approved
Approval ID
a6546625-acb8-460e-b34e-f795bfb3680a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Sigmapharm Laboratories, LLC
DUNS: 556234636
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ACITRETIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-080
Application NumberANDA204633
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACITRETIN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (9)
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ACITRETINActive
Quantity: 10 mg in 1 1
Code: LCH760E9T7
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ACITRETIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-081
Application NumberANDA204633
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACITRETIN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (10)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ACITRETINActive
Quantity: 17.5 mg in 1 1
Code: LCH760E9T7
Classification: ACTIB
ACITRETIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-083
Application NumberANDA204633
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACITRETIN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ACITRETINActive
Quantity: 25 mg in 1 1
Code: LCH760E9T7
Classification: ACTIB