Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sigmapharm Laboratories, LLC
Sigmapharm Laboratories, LLC
556234636
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ACITRETIN
Product Details
NDC Product Code
42794-080Application Number
ANDA204633Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 10, 2023MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 10 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
ACITRETIN
Product Details
NDC Product Code
42794-081Application Number
ANDA204633Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 10, 2023POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 17.5 mg in 1 1
ACITRETIN
Product Details
NDC Product Code
42794-083Application Number
ANDA204633Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 10, 2023CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 25 mg in 1 1