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Details for New Drug Application (NDA): 200199

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NDA 200199 describes TOPOTECAN, which is a drug marketed by Sandoz Inc, Sun Pharm Inds Ltd, Actavis Totowa, Mylan Labs Ltd, Accord Hlthcare, Teva Pharms Usa, Chem Werth Inc, Fresenius Kabi Oncol, Hospira Inc, Sagent Pharms, Fresenius Kabi Usa, Dr Reddys Labs Ltd, and Cipla Ltd, and is included in thirteen NDAs. It is available from one supplier. Additional details are available on the TOPOTECAN profile page.

The generic ingredient in TOPOTECAN is topotecan hydrochloride. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

Summary for NDA: 200199

Tradename:
TOPOTECAN
Applicant:
Sandoz Inc
Ingredient:
topotecan hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 200199

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 200199

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN
topotecan hydrochloride
SOLUTION;INTRAVENOUS 200199 NDA Sandoz Inc 66758-051 66758-051-01 1 VIAL, MULTI-DOSE in 1 CARTON (66758-051-01) > 1 mL in 1 VIAL, MULTI-DOSE
TOPOTECAN
topotecan hydrochloride
SOLUTION;INTRAVENOUS 200199 NDA Sandoz Inc 66758-051 66758-051-03 1 VIAL, MULTI-DOSE in 1 CARTON (66758-051-03) > 3 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 25, 2011TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 25, 2011TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 25, 2011TE:RLD:No


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