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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205487

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NDA 205487 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, Fresenius Kabi Oncol, Gland Pharma Ltd, Ingenus Pharms Llc, Mylan Institutional, Nanjing King-friend, Pharmachemie Bv, Pliva Lachema, Sandoz Inc, Sanja Pharms Co, 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 205487
Tradename:CARBOPLATIN
Applicant:Sanja Pharms Co
Ingredient:carboplatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205487
Medical Subject Heading (MeSH) Categories for 205487
Suppliers and Packaging for NDA: 205487
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBOPLATIN carboplatin INJECTABLE;IV (INFUSION) 205487 ANDA Sanja Pharmaceuticals Company 57277-105 E 57277-105-05
CARBOPLATIN carboplatin INJECTABLE;IV (INFUSION) 205487 ANDA Sanja Pharmaceuticals Company 57277-106 E 57277-106-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/5ML (10MG/ML)
Approval Date:Mar 28, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength150MG/15ML (10MG/ML)
Approval Date:Mar 28, 2016TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength450MG/45ML (10MG/ML)
Approval Date:Mar 28, 2016TE:APRLD:No

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