← FDA Drug Approvals (Drugs@FDA)

ROSUVASTATIN CALCIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACCORD HLTHCARE · Approved 2016-10-31

Drug application

FDA Application #

ANDA206434

Application type

Abbreviated New Drug Application (Generic)

Brand name

ROSUVASTATIN CALCIUM

Generic name

ROSUVASTATIN

Active ingredients

ROSUVASTATIN CALCIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ACCORD HLTHCARE

Manufacturer

Accord Healthcare Inc.

First approval

2016-10-31

Source

Authoritative

Drugs@FDA application overview

Machine

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