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FDA Approval

Phendimetrazine Tartrate

CompanyA-S Medication Solutions (DUNS: 830016429)

Effective Date

April 16, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Phendimetrazine(35 mg in 1 1)

Manufacturing Establishments (1)

A-S Medication Solutions

Labeler

A-S Medication Solutions

DUNS Number

830016429

Products (1)

Phendimetrazine Tartrate

NDC Product Code

50090-3976

Application Number

ANDA091042

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 11, 2019

Ingredients

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1MClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

PhendimetrazineActive

Code: 6985IP0T80Class: ACTIBQuantity: 35 mg in 1 1

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