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FLURBIPROFEN

Approved
Approval ID

9ce60fd6-b58b-4b7c-835d-305107552f44

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 15, 2009

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

FLURBIPROFEN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16590-096
Application NumberANDA074358
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLURBIPROFEN
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2009
FDA Product Classification

INGREDIENTS (1)

FLURBIPROFENActive
Quantity: 100 mg in 1 1
Code: 5GRO578KLP
Classification: ACTIB

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FLURBIPROFEN - FDA Drug Approval Details