FDA Product

NAPROXEN

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

NAPROXEN

FDA Product Code

52605-140

Regulatory Information

NDC Product Code

52605-140

Application Number

ANDA091416

Marketing Category

C73584

Effective Date

June 28, 2013

Territorial Authority

USA

FDA Title

Naproxen Tablets, USP 250mg, 375mg, 500 mg

Labeling Type

Human Prescription Drug Label

Version Number

6

Company Information

ManufacturerPolygen Pharmaceuticals LLC

DUNS Number

962415720

Active Ingredients

POVIDONE

Code: FZ989GH94E

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Quantity: 500 mg in 1 1

Code: 57Y76R9ATQ

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

Active Moieties

NAPROXEN

Code: 57Y76R9ATQ

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