180 TABLET, FILM COATED ( TABLET) in 1 BOTTLE

None
Marketing Information

Marketing Category

Application Number or Monograph Citation

Marketing Start Date

Marketing End Date

NDA

NDA202324

01/27/2012

INLYTA
axitinib tablet, film coated
Product Information
Product Type

HUMAN PRESCRIPTION DRUG

Item Code (Source)

NDC:0069-0151

Route of Administration

ORAL

DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Strength

axitinib (axitinib)

axitinib

5 mg

Inactive Ingredients

Ingredient Name

Strength

cellulose, microcrystalline

lactose monohydrate

croscarmellose sodium

magnesium stearate

titanium dioxide

triacetin

ferric oxide red

HYPROMELLOSE 2910 (15000 MPA.S)

Product Characteristics

Color

RED

Score

 no score

Shape

TRIANGLE

Size

8mm

Flavor
Imprint Code

Pfizer;5;XNB

Contains

Packaging
#
Item Code

Package Description

Multilevel Packaging

1
NDC:0069-0151-11

60 TABLET, FILM COATED ( TABLET) in 1 BOTTLE

None

Marketing Information

Marketing Category

Application Number or Monograph Citation

Marketing Start Date

Marketing End Date

NDA

NDA202324

01/27/2012

Labeler - Pfizer Laboratories Div Pfizer Inc (134489525)

Establishment

Name

Address

ID/FEI

Operations

Pfizer Ireland Pharmaceuticals

989811526

API MANUFACTURE

Establishment

Name

Address

ID/FEI

Operations

Pfizer Manufacturing Deutschland GmBH

341970073

MANUFACTURE

Establishment

Name

Address

ID/FEI

Operations

Pfizer Pharmaceuticals LLC

829084552

PACK, ANALYSIS