PACLITAXEL PACLITAXEL: Package Insert and Label Information (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Paclitaxel Injection, USP
30 mg/5 mL, 6 mg/mL
Rx only
CAUTION: DILUTION REQUIRED
PRIOR TO IV INFUSION
Multiple Dose Vial Cytotoxic Agent

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Paclitaxel Injection, USP
100 mg/16.7 mL, 6 mg/mL
Rx only
CAUTION: DILUTION REQUIRED
PRIOR TO IV INFUSION
Multiple Dose Vial Cytotoxic Agent

Image-11
(click image for full-size original)

Paclitaxel Injection, USP
300 mg/50 mL, 6 mg/mL
Rx only
CAUTION: DILUTION REQUIRED
PRIOR TO IV INFUSION
Multiple Dose Vial Cytotoxic Agent

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(click image for full-size original)
PACLITAXEL PACLITAXEL paclitaxel injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-178
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL (PACLITAXEL) PACLITAXEL 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 35 CASTOR OIL
ALCOHOL
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68083-178-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (68083-178-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207326 09/30/2016
PACLITAXEL PACLITAXEL paclitaxel injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-179
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL (PACLITAXEL) PACLITAXEL 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 35 CASTOR OIL
ALCOHOL
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68083-179-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 16.7 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (68083-179-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207326 09/30/2016
PACLITAXEL PACLITAXEL paclitaxel injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-180
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL (PACLITAXEL) PACLITAXEL 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 35 CASTOR OIL
ALCOHOL
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68083-180-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (68083-180-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207326 09/30/2016
Labeler — Gland Pharma Limited (918601238)
Establishment
Name Address ID/FEI Operations
Gland Pharma Limited 650540227 ANALYSIS (68083-178), ANALYSIS (68083-179), ANALYSIS (68083-180), MANUFACTURE (68083-178), MANUFACTURE (68083-179), MANUFACTURE (68083-180)

Revised: 09/2016 Gland Pharma Limited

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