HALOG
HALOG SOLUTION (Halcinonide Topical Solution, USP) 0.1 % For Topical Use Only. Not For Ophthalmic Use.
Approved
Approval ID
550b8c9f-e5a8-48c4-a3ff-1a56a3caac33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 18, 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 Topical
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10631-095
Application NumberNDA017823
Product Classification
M
Marketing Category
C73594
G
Generic Name
Halcinonide Topical
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 18, 2021
FDA Product Classification
INGREDIENTS (5)
HALCINONIDEActive
Quantity: 1 mg in 1 mL
Code: SI86V6QNEG
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT