← FDA Drug Approvals (Drugs@FDA)

EZETIMIBE AND SIMVASTATIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2019-06-27

Drug application

FDA Application #

ANDA208699

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

GLENMARK PHARMS LTD

Manufacturer

Glenmark Pharmaceuticals Inc., USA

First approval

2019-06-27

Source

Authoritative

Drugs@FDA application overview

Machine

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