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Last Updated: September 27, 2020

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Details for New Drug Application (NDA): 077247

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NDA 077247 describes CARBOPLATIN, which is a drug marketed by Cipla Ltd, Eugia Pharma, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Pliva, Sandoz, Watson Labs Teva, West-ward Pharms Int, Accord Hlthcare, Actavis Totowa, Akorn, Gland Pharma Ltd, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Pharmachemie Bv, Pliva Lachema, Sandoz Inc, Sun Pharm, Teva Parenteral, and Teva Pharms Usa, and is included in thirty-three NDAs. It is available from nine 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. Nine suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
Summary for 077247
Tradename:CARBOPLATIN
Applicant:Fresenius Kabi Usa
Ingredient:carboplatin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 077247

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength50MG/5ML (10MG/ML)
Approval Date:Oct 21, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength150MG/15ML (10MG/ML)
Approval Date:Oct 21, 2004TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength450MG/45ML (10MG/ML)
Approval Date:Oct 21, 2004TE:APRLD:No

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