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Generated: July 26, 2017

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Details for New Drug Application (NDA): 200582

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NDA 200582 describes TOPOTECAN HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds Ltd, Accord Hlthcare, Actavis Totowa, Mylan Labs Ltd, Teva Pharms Usa, Ingenus Pharms Llc, Chem Werth Inc, Fresenius Kabi Oncol, Hospira Inc, Sagent Pharms, Fresenius Kabi Usa, Dr Reddys Labs Ltd, and Cipla Ltd, and is included in fourteen NDAs. It is available from eleven suppliers. Additional details are available on the TOPOTECAN HYDROCHLORIDE profile page.

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

Summary for NDA: 200582

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 200582

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 200582

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN HYDROCHLORIDE
topotecan hydrochloride
SOLUTION;INTRAVENOUS 200582 NDA Hospira, Inc. 0409-0302 0409-0302-01 1 VIAL, SINGLE-USE in 1 CARTON (0409-0302-01) > 4 mL in 1 VIAL, SINGLE-USE
TOPOTECAN HYDROCHLORIDE
topotecan hydrochloride
SOLUTION;INTRAVENOUS 200582 NDA Hospira, Inc. 0409-0302 0409-0302-25 1 VIAL, SINGLE-USE in 1 CARTON (0409-0302-25) > 4 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date:Feb 2, 2011TE:APRLD:Yes


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Serving 500+ biopharmaceutical companies globally:

McKesson
Fish and Richardson
Accenture
US Department of Justice
QuintilesIMS
AstraZeneca
Johnson and Johnson
Moodys
Boehringer Ingelheim
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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