Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Preferred Pharmaceuticals Inc.
791119022
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
791119022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Permethrin
Product Details
NDC Product Code
68788-8439Application Number
ANDA211303Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
June 5, 2023MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31Class: IACT
GLYCERYL MONO AND DIPALMITOSTEARATEInactive
Code: KC98RO82HJClass: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HEClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
CETETH-20Inactive
Code: I835H2IHHXClass: IACT
FORMALDEHYDEInactive
Code: 1HG84L3525Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PermethrinActive
Code: 509F88P9SZClass: ACTIBQuantity: 50 mg in 1 g