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EZETIMIBE AND SIMVASTATIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA USA · Approved 2020-12-17

Drug application

FDA Application #

ANDA200082

Application type

Abbreviated New Drug Application (Generic)

Brand name

EZETIMIBE AND SIMVASTATIN

Generic name

EZETIMIBE AND SIMVASTATIN

Active ingredients

EZETIMIBE; SIMVASTATIN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA USA

Manufacturer

Aurobindo Pharma Limited

First approval

2020-12-17

Source

Authoritative

Drugs@FDA application overview

Machine

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