FDA Product

Halog

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Halog

FDA Product Code

10631-094

Regulatory Information

NDC Product Code

10631-094

Application Number

NDA017556

Marketing Category

C73594

Effective Date

January 7, 2019

Territorial Authority

USA

FDA Title

HALOG (Halcinonide Cream, USP) 0.1%

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

7

Company Information

ManufacturerSun Pharmaceutical Industries, Inc.

DUNS Number

146974886

Active Ingredients

GLYCERYL MONOSTEARATE

Code: 230OU9XXE4

Class Code: IACT

CETYL ALCOHOL

Code: 936JST6JCN

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Quantity: 1 mg in 1 g

Code: SI86V6QNEG

Class Code: ACTIB

ISOPROPYL PALMITATE

Code: 8CRQ2TH63M

Class Code: IACT

POLYSORBATE 60

Code: CAL22UVI4M

Class Code: IACT

DIMETHICONE 350

Code: 2Y53S6ATLU

Class Code: IACT

Active Moieties

HALCINONIDE

Code: SI86V6QNEG

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