HALOG

Basic Information

Product Name

HALOG

FDA Product Code

10631-095

Regulatory Information

NDC Product Code

10631-095

Application Number

NDA017823

Marketing Category

C73594

Effective Date

May 18, 2021

Territorial Authority

USA

FDA Title

HALOG SOLUTION (Halcinonide Topical Solution, USP) 0.1 % For Topical Use Only. Not For Ophthalmic Use.

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HALCINONIDE

Quantity: 1 mg in 1 mL

Code: SI86V6QNEG

Class Code: ACTIB

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

POLYETHYLENE GLYCOL 300

Code: 5655G9Y8AQ

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

BUTYLATED HYDROXYTOLUENE

Code: 1P9D0Z171K

Class Code: IACT

Active Moieties

HALCINONIDE

Code: SI86V6QNEG

Basic Information

Regulatory Information

Company Information

Active Ingredients

EDETATE DISODIUM

POLYETHYLENE GLYCOL 300

WATER

BUTYLATED HYDROXYTOLUENE

Active Moieties

HALCINONIDE