ROSUVASTATIN

Product NDC

60505-2885

11-digit product format

605052885

Labeler code

60505

Product ID

60505-2885_195b28af-0c20-0222-bac1-3495fb0a9db5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ROSUVASTATIN CALCIUM

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Apotex Corp.

Application

ANDA079145

Marketing category

ANDA

Marketing start

2017-08-29

Marketing end

0000-00-00

Substance

ROSUVASTATIN CALCIUM

Active strength

5 mg/1

Pharmacologic classes

HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record