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FDA Approval

Benzphetamine Hydrochloride

CompanyApotheca Inc. (DUNS: 051457844)

Effective Date

January 25, 2017

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Benzphetamine(50 mg in 1 1)

Manufacturing Establishments (1)

Labeler

Apotheca Inc.

DUNS Number

051457844

Products (1)

Benzphetamine Hydrochloride

NDC Product Code

12634-118

Application Number

ANDA040747

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 25, 2017

Ingredients

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

LACTOSEInactive

Code: J2B2A4N98GClass: IACT

CALCIUM STEARATEInactive

Code: 776XM7047LClass: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

BenzphetamineActive

Code: 43DWT87QT7Class: ACTIBQuantity: 50 mg in 1 1

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