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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Paclitaxel injection-30 mg/5ml-vial-label

30mg-5ml-vial-label
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Paclitaxel injection-30 mg/5ml-carton-label
30mg-5ml-carton-label
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Paclitaxel injection-100 mg/16.7ml-vial-label
100mg-16-7ml-vial-label
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Paclitaxel injection-100 mg/16.7ml-carton-label
100mg-16-7ml-carton-label
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Paclitaxel injection-300 mg/50ml-vial-label
300mg-50ml-vial-label
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300mg-50ml-carton-label
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PACLITAXEL paclitaxel injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-061
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
CASTOR OIL
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-061-01 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 (72205-061-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213434 08/26/2020
PACLITAXEL paclitaxel injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-062
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
CASTOR OIL
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-062-01 01 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 (72205-062-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213434 08/26/2020
PACLITAXEL paclitaxel injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-063
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
CASTOR OIL
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-063-01 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 (72205-063-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213434 08/26/2020
Labeler — Novadoz Pharmaceuticals LLC (081109687)
Establishment
Name Address ID/FEI Operations
MSN LABORATORIES PRIVATE LIMITED 650786952 ANALYSIS (72205-061), ANALYSIS (72205-062), ANALYSIS (72205-063), MANUFACTURE (72205-061), MANUFACTURE (72205-062), MANUFACTURE (72205-063)

Revised: 08/2020 Novadoz Pharmaceuticals LLC

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