INLYTA (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 1 mg Tablet Bottle Label

Pfizer

NDC 0069-0145-01

Inlyta^® (axitinib) tablets

1 mg

180 Tablets

Rx only

PRINCIPAL DISPLAY PANEL — 5 mg Tablet Bottle Label

Pfizer

NDC 0069-0151-11

Inlyta^® (axitinib) tablets

5 mg

60 Tablets

Rx only

INLYTA axitinib tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0145 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AXITINIB (AXITINIB) AXITINIB 1 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE 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 OVAL Size 9mm Flavor Imprint Code Pfizer;1;XNB Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0069-0145-01 180 TABLET, FILM COATED 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 MICROCRYSTALLINE CELLULOSE 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 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
Upjohn Manufacturing Ireland Unlimited Company		986030667	ANALYSIS (0069-0145), ANALYSIS (0069-0151), API MANUFACTURE (0069-0145), API MANUFACTURE (0069-0151)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Manufacturing Deutschland GmbH		341970073	ANALYSIS (0069-0145), ANALYSIS (0069-0151), MANUFACTURE (0069-0145), MANUFACTURE (0069-0151), PACK (0069-0145), PACK (0069-0151), LABEL (0069-0145), LABEL (0069-0151)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Ireland Pharmaceuticals		985052076	ANALYSIS (0069-0145), ANALYSIS (0069-0151), API MANUFACTURE (0069-0145), API MANUFACTURE (0069-0151)

Revised: 10/2023 Pfizer Laboratories Div Pfizer Inc