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Generated: October 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076517

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NDA 076517 describes CARBOPLATIN, which is a drug marketed by Cipla Ltd, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Pliva, Sandoz, Watson Labs Teva, West-ward Pharms Int, Accord Hlthcare, Actavis Totowa, Akorn, Eugia Pharma, Fresenius Kabi Oncol, Gland Pharma Ltd, Ingenus Pharms Llc, Mylan Institutional, Nanjing King-friend, Pharmachemie Bv, Pliva Lachema, Sandoz Inc, Sun Pharma Global, Teva Parenteral, and Teva Pharms Usa, and is included in thirty-three NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
Summary for 076517
Tradename:CARBOPLATIN
Applicant:Hospira
Ingredient:carboplatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076517
Medical Subject Heading (MeSH) Categories for 076517
Suppliers and Packaging for NDA: 076517
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBOPLATIN carboplatin INJECTABLE;IV (INFUSION) 076517 ANDA Hospira, Inc. 61703-339 61703-339-18 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-18) > 5 mL in 1 VIAL, MULTI-DOSE
CARBOPLATIN carboplatin INJECTABLE;IV (INFUSION) 076517 ANDA Hospira, Inc. 61703-339 61703-339-22 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-22) > 15 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/5ML (10MG/ML)
Approval Date:Oct 14, 2004TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength150MG/15ML (10MG/ML)
Approval Date:Oct 14, 2004TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength450MG/45ML (10MG/ML)
Approval Date:Oct 14, 2004TE:APRLD:No

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