Halcinonide
Approved
Approval ID
b7d78c72-a683-4208-b7dd-5523502c036c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2019
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Halcinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-8056
Application NumberANDA211027
Product Classification
M
Marketing Category
C73584
G
Generic Name
Halcinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 30, 2019
FDA Product Classification
INGREDIENTS (10)
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
HALCINONIDEActive
Quantity: 1 mg in 1 g
Code: SI86V6QNEG
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT