Rosuvastatin Calcium

Product NDC

42292-031

11-digit product format

422920031

Labeler code

42292

Product ID

42292-031_7d8ee399-0c5f-a796-e053-2a91aa0a607f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

rosuvastatin calcium

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA079161

Marketing category

ANDA

Marketing start

2016-08-16

Marketing end

2019-05-31

Substance

ROSUVASTATIN CALCIUM

Active strength

20 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record