Halog
HALOG (Halcinonide Cream, USP) 0.1%
Approved
Approval ID
e60d0691-0628-4c98-9a17-f4a89822baf2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 7, 2019
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 Cream
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10631-094
Application NumberNDA017556
Product Classification
M
Marketing Category
C73594
G
Generic Name
Halcinonide Cream
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 7, 2019
FDA Product Classification
INGREDIENTS (9)
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HALCINONIDEActive
Quantity: 1 mg in 1 g
Code: SI86V6QNEG
Classification: ACTIB
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT