← FDA Drug Approvals (Drugs@FDA)

ROSUVASTATIN CALCIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2017-03-21

Drug application

FDA Application #

ANDA206465

Application type

Abbreviated New Drug Application (Generic)

Brand name

ROSUVASTATIN CALCIUM

Generic name

ROSUVASTATIN CALCIUM

Active ingredients

ROSUVASTATIN CALCIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

Manufacturer

Ascend Laboratories, LLC

First approval

2017-03-21

Source

Authoritative

Drugs@FDA application overview

Machine

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