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Details for New Drug Application (NDA): 091063

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NDA 091063 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, Akorn, Pharmachemie Bv, Accord Hlthcare, Sandoz Inc, Sanja Pharms Co, Teva Parenteral, Nanjing King-friend, and Mylan Institutional, and is included in thirty-two NDAs. It is available from nine 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. Nine suppliers are listed for this compound. Additional details are available on the carboplatin profile page.

Summary for NDA: 091063

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

Pharmacology for NDA: 091063

Suppliers and Packaging for NDA: 091063

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBOPLATIN
carboplatin
INJECTABLE;IV (INFUSION) 091063 ANDA Mylan Institutional LLC 67457-491 67457-491-54 1 VIAL in 1 CARTON (67457-491-54) > 5 mL in 1 VIAL
CARBOPLATIN
carboplatin
INJECTABLE;IV (INFUSION) 091063 ANDA Mylan Institutional LLC 67457-492 67457-492-15 1 VIAL in 1 CARTON (67457-492-15) > 15 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/5ML (10MG/ML)
Approval Date:Nov 9, 2011TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength150MG/15ML (10MG/ML)
Approval Date:Nov 9, 2011TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength450MG/45ML (10MG/ML)
Approval Date:Nov 9, 2011TE:APRLD:No


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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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