HALOG
(Halcinonide Ointment, USP) 0.1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Rx only
Approved
Approval ID
4f6ffa29-577b-4377-a068-0846df221771
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 29, 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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10631-096
Application NumberNDA017824
Product Classification
M
Marketing Category
C73594
G
Generic Name
HALCINONIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 29, 2019
FDA Product Classification
INGREDIENTS (7)
HALCINONIDEActive
Quantity: 1 mg in 1 g
Code: SI86V6QNEG
Classification: ACTIB
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT