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Details for New Drug Application (NDA): 091478

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NDA 091478 describes CARBOPLATIN, which is a drug marketed by Pliva, Mylan Labs Ltd, Hospira, Sun Pharma Global, Pliva Lachema, Actavis Totowa, Fresenius Kabi Oncol, Fresenius Kabi Usa, Teva Pharms Usa, West-ward Pharms Int, Sandoz, Cipla Ltd, Watson Labs, Akorn, Pharmachemie Bv, Sandoz Inc, Sanja Pharms Co, Teva Parenteral, Nanjing King-friend, and Mylan Institutional, and is included in thirty NDAs. It is available from eight suppliers. Additional details are available on the CARBOPLATIN profile page.

The generic ingredient in CARBOPLATIN is carboplatin. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the carboplatin profile page.

Summary for NDA: 091478

Tradename:
CARBOPLATIN
Applicant:
Mylan Labs Ltd
Ingredient:
carboplatin
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength1GM/100ML (10MG/ML)
Approval Date:Nov 23, 2011TE:RLD:Yes


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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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