← FDA Drug Approvals (Drugs@FDA)

ROSUVASTATIN CALCIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2016-07-19

Drug application

FDA Application #

ANDA079170

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

AUROBINDO PHARMA LTD

Manufacturer

Rising Pharma Holdings, Inc.

First approval

2016-07-19

Source

Authoritative

Drugs@FDA application overview

Machine

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