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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 207324


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NDA 207324 describes CARBOPLATIN, which is a drug marketed by Cipla Ltd, Fresenius Kabi Usa, Hikma, Hospira, Natco Pharma Usa, Pliva, Sandoz, Watson Labs Teva, Accord Hlthcare, Actavis Totowa, Epic Pharma Llc, Eugia Pharma, Gland, Meitheal, Novast Labs, Pharmachemie Bv, Pharmobedient, Pliva Lachema, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Teyro Labs, and is included in thirty-three NDAs. It is available from ten 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. Eleven suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
Summary for 207324
Tradename:CARBOPLATIN
Applicant:Gland
Ingredient:carboplatin
Patents:0
Pharmacology for NDA: 207324
Medical Subject Heading (MeSH) Categories for 207324
Antineoplastic Agents
Cross-Linking Reagents
Suppliers and Packaging for NDA: 207324
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBOPLATIN carboplatin INJECTABLE;INTRAVENOUS 207324 ANDA BPI Labs LLC 54288-164 54288-164-01 1 VIAL, MULTI-DOSE in 1 CARTON (54288-164-01) / 5 mL in 1 VIAL, MULTI-DOSE
CARBOPLATIN carboplatin INJECTABLE;INTRAVENOUS 207324 ANDA BPI Labs LLC 54288-165 54288-165-01 1 VIAL, MULTI-DOSE in 1 CARTON (54288-165-01) / 15 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/5ML (10MG/ML)
Approval Date:Feb 15, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength150MG/15ML (10MG/ML)
Approval Date:Feb 15, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength450MG/45ML (10MG/ML)
Approval Date:Feb 15, 2017TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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