TOPOTECAN- topotecan injection, solution, concentrate 
Mylan Laboratories Limited

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TOPOTECAN INJECTION

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 67457-662-05

Topotecan Injection

4 mg/4 mL (1 mg/mL)

Must Dilute Before Intravenous Infusion

CAUTION: CYTOTOXIC AGENT

Discard unused portion

Sterile

Mylan

Rx only

Single-Dose Vial

Carton
TOPOTECAN 
topotecan injection, solution, concentrate
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:47351-052
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPOTECAN HYDROCHLORIDE (UNII: 956S425ZCY) (TOPOTECAN - UNII:7M7YKX2N15) TOPOTECAN1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TARTARIC ACID (UNII: W4888I119H) 5 mg  in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47351-052-041 in 1 CARTON12/31/2017
14 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractANDA20607412/31/2017
Labeler - Mylan Laboratories Limited (650548014)

Revised: 12/2017
Document Id: 5c6b8273-1785-452d-b73e-1f2bb2b54758
Set id: 5c6b8273-1785-452d-b73e-1f2bb2b54758
Version: 1
Effective Time: 20171201
 
Mylan Laboratories Limited