.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Find suppliers and generic API sources
  • Identify first generic entrants

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Cipla
Queensland Health
UBS
Citi
Argus Health
Baxter
Teva
Express Scripts
Daiichi Sankyo
Fuji

Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091199

« Back to Dashboard
NDA 091199 describes TOPOTECAN HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds Ltd, Actavis Totowa, Mylan Labs Ltd, Accord Hlthcare, 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 thirteen 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: 091199

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

Pharmacology for NDA: 091199

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 091199

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPOTECAN HYDROCHLORIDE
topotecan hydrochloride
INJECTABLE;INJECTION 091199 ANDA Three Rivers Pharmaceuticals, LLC. 66435-410 66435-410-01 1 VIAL, GLASS in 1 CARTON (66435-410-01) > 4 mL in 1 VIAL, GLASS
TOPOTECAN HYDROCHLORIDE
topotecan hydrochloride
INJECTABLE;INJECTION 091199 ANDA Three Rivers Pharmaceuticals, LLC. 66435-410 66435-410-05 5 VIAL, GLASS in 1 CARTON (66435-410-05) > 4 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/VIAL
Approval Date:Dec 1, 2010TE:APRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Citi
Colorcon
Merck
Fuji
US Department of Justice
AstraZeneca
Healthtrust
Harvard Business School
Farmers Insurance
Covington

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot