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Serving leading biopharmaceutical companies globally:

Moodys
Chinese Patent Office
Cantor Fitzgerald
Argus Health
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Farmers Insurance
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Baxter
Federal Trade Commission
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Generated: November 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205487

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NDA 205487 describes CARBOPLATIN, which is a drug marketed by Pliva, Mylan Labs Ltd, Hospira, Gland Pharma Ltd, Sun Pharma Global, Pliva Lachema, Actavis Totowa, Fresenius Kabi Oncol, Fresenius Kabi Usa, Teva Pharms Usa, West-ward Pharms Int, Sandoz, Cipla Ltd, Watson Labs Teva, Akorn, Pharmachemie Bv, Accord Hlthcare, Sandoz Inc, Ingenus Pharms Llc, Sanja Pharms Co, Teva Parenteral, Nanjing King-friend, and Mylan Institutional, 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:
1
Applicant:
1
Ingredient:
1
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 57277-105-05 1 VIAL, MULTI-DOSE in 1 CARTON (57277-105-05) > 5 mL in 1 VIAL, MULTI-DOSE
CARBOPLATIN
carboplatin
INJECTABLE;IV (INFUSION) 205487 ANDA Sanja Pharmaceuticals Company 57277-106 57277-106-15 1 VIAL, MULTI-DOSE in 1 CARTON (57277-106-15) > 5 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving leading biopharmaceutical companies globally:

Healthtrust
Federal Trade Commission
Teva
Fish and Richardson
Novartis
Citi
Harvard Business School
Mallinckrodt
Johnson and Johnson
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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