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FDA Approval

DORAL

CompanyGalt Pharmaceuticals, LLC (DUNS: 079214973)

Effective Date

January 31, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Quazepam(15 mg in 1 1)

Products (1)

DORAL

NDC Product Code

61825-165

Application Number

NDA018708

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 31, 2023

Ingredients

POWDERED CELLULOSEInactive

Code: SMD1X3XO9MClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

LACTOSEInactive

Code: J2B2A4N98GClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Code: JF8V0828ZIClass: ACTIBQuantity: 15 mg in 1 1

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

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