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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077096

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NDA 077096 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 077096

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 077096

Medical Subject Heading (MeSH) Categories for 077096

Suppliers and Packaging for NDA: 077096

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBOPLATIN carboplatin INJECTABLE;IV (INFUSION) 077096 ANDA Sagent Pharmaceuticals 25021-202 25021-202-51 1 VIAL in 1 CARTON (25021-202-51) > 60 mL in 1 VIAL
CARBOPLATIN carboplatin INJECTABLE;IV (INFUSION) 077096 ANDA Sagent Pharmaceuticals 25021-202 25021-202-05 1 VIAL in 1 CARTON (25021-202-05) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/5ML (10MG/ML)
Approval Date:Jun 14, 2005TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength150MG/15ML (10MG/ML)
Approval Date:Jun 14, 2005TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength450MG/45ML (10MG/ML)
Approval Date:Jun 14, 2005TE:APRLD:No


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