Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Gabar Health Sciences Corp.
118401847
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
UREA 40%
Product Details
NDC Product Code
82429-308Route of Administration
TOPICALEffective Date
October 21, 2023PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJCClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
UreaActive
Code: 8W8T17847WClass: ACTIBQuantity: 40 g in 100 g