HALCINONIDE
Halcinonide Cream, USP, 0.1%
Approved
Approval ID
aed461bb-e49e-44c4-b42f-b5b261c072a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 27, 2021
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code57664-698
Application NumberNDA017556
Product Classification
M
Marketing Category
C73605
G
Generic Name
HALCINONIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 2021
FDA Product Classification
INGREDIENTS (9)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HALCINONIDEActive
Quantity: 1 mg in 1 g
Code: SI86V6QNEG
Classification: ACTIB
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT