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Details for New Drug Application (NDA): 202203

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NDA 202203 describes TOPOTECAN HYDROCHLORIDE, which is a drug marketed by 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 twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

Summary for NDA: 202203

Tradename:
TOPOTECAN HYDROCHLORIDE
Applicant:
Sun Pharm Inds Ltd
Ingredient:
topotecan hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 202203

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 202203

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN HYDROCHLORIDE
topotecan hydrochloride
INJECTABLE;INJECTION 202203 ANDA Sun Pharmaceutical Industries Limited 62756-023 62756-023-40 1 VIAL, SINGLE-USE in 1 PACKAGE (62756-023-40) > 4 mL in 1 VIAL, SINGLE-USE
TOPOTECAN HYDROCHLORIDE
topotecan hydrochloride
INJECTABLE;INJECTION 202203 ANDA Sun Pharmaceutical Industries Limited 62756-023 62756-023-43 5 VIAL, SINGLE-DOSE in 1 PACKAGE (62756-023-43) > 4 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/VIAL
Approval Date:Aug 29, 2013TE:APRLD:No


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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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