DOCEFREZ (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DOCEFREZ-20MG-LABEL

NDC 47335-285-40
DocefrezTM
(Docetaxel) for Injection
20 mg
For Intravenous Infusion Only
Each Docefrez for Injection vial contains a slight overfill to deliver 20 mg of Docetaxel per 0.8 mL after reconstitution Rx ONLY

docetaxel-lbl-20mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DOCEFREZ-20MG-CARTON

NDC 47335-285-41
DocefrezTM
(Docetaxel) for Injection
20 mg*
For Intravenous Infusion Only
*Each Docefrez for Injection vial contains a slight overfill to deliver 20 mg of Docetaxel per 0.8 mL after reconstitution
Each carton contains:
One vial of Docefrez (docetaxel) for Injection 20 mg
One vial of DILUENT for Docefrez 20 mg Rx ONLY

docetaxel-carton-20mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DILUENT-20MG-LABEL

NDC 47335-287-40
DILUENT for DocefrezTM 20 mg
1.13 mL
Single Use Vial-Discard Unused Portion. Rx ONLY

docetaxel-diluent-lbl-20mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DOCEFREZ-80MG-LABEL

NDC 47335-286-40
DocefrezTM
(Docetaxel) for Injection
80 mg
For Intravenous Infusion Only
Each Docefrez for Injection vial contains a slight overfill to deliver 80 mg of Docetaxel (24 mg/mL after reconstitution)

docetaxel-lbl-80mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DOCEFREZ-80MG-CARTON

NDC 47335-286-41
DocefrezTM
(Docetaxel) for Injection
80 mg*
For Intravenous Infusion Only
*Each Docefrez for Injection vial contains a slight overfill to deliver 80 mg of Docetaxel (24 mg/mL after reconstitution)
Each carton contains:
One vial of Docefrez (docetaxel) for Injection 80 mg
One vial of DILUENT for Docefrez 80 mg Rx ONLY

docetaxel-carton-80mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DILUENT-80MG-LABEL

NDC 47335-288-40
DILUENT for DocefrezTM 80 mg
4.21 mL
Rx ONLY

docetaxel-diluent-lbl-80mg
(click image for full-size original)

DOCEFREZ docetaxel anhydrous kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-285
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-285-41 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-USE 0.25 mL
Part 2 1 VIAL, SINGLE-USE 1.13 mL
Part 1 of 2
DOCEFREZ docetaxel anhydrous injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL ANHYDROUS (DOCETAXEL ANHYDROUS) DOCETAXEL ANHYDROUS 20 mg in 0.8 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 0.25 mL in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022534 05/03/2011
Part 2 of 2
DILUENT diluent solution
Product Information
Item Code (Source) NDC:47335-287
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-287-40 1.13 mL in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022534 05/03/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022534 05/03/2011
Labeler — Sun Pharma Global FZE (864347344)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (47335-285), MANUFACTURE (47335-285)

Revised: 11/2014 Sun Pharma Global FZE

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