Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
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
72162-2223Application Number
ANDA204633Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 25, 2024POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 25 mg in 1 1