Fluvastatin Sodium

Product NDC

0378-5121

11-digit product format

003785121

Labeler code

0378

Product ID

0378-5121_385f9f12-0e8d-459d-a83c-56b9fb5892cc

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

fluvastatin

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA202458

Marketing category

ANDA

Marketing start

2015-09-11

Marketing end

2019-07-31

Substance

FLUVASTATIN SODIUM

Active strength

80 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