Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Micro-Sphere SA
Amneal Pharmaceuticals of New York LLC
480285043
Douglas Manufacturing Limited
Amneal Pharmaceuticals of New York LLC
590829388
Products4
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
0115-1751Application Number
ANDA202552Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2023AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 17.5 mg in 1 1
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
Acitretin
Product Details
NDC Product Code
0115-1752Application Number
ANDA202552Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2023AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 22.5 mg in 1 1
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
Acitretin
Product Details
NDC Product Code
0115-1750Application Number
ANDA202552Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2023AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 10 mg in 1 1
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
Acitretin
Product Details
NDC Product Code
0115-1753Application Number
ANDA202552Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2023MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 25 mg in 1 1
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT