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Serving 500+ biopharmaceutical companies globally:

Baxter
Covington
Queensland Health
Julphar
Moodys
Fuji
Deloitte
Cerilliant
Farmers Insurance
Colorcon

Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202543

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NDA 202543 describes LEVETIRACETAM IN SODIUM CHLORIDE, which is a drug marketed by Hq Speciality Pharma and Aurobindo Pharma Ltd and is included in two NDAs. It is available from two suppliers. Additional details are available on the LEVETIRACETAM IN SODIUM CHLORIDE profile page.

The generic ingredient in LEVETIRACETAM IN SODIUM CHLORIDE is levetiracetam. There are thirty-five drug master file entries for this compound. Ninety-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

Summary for NDA: 202543

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 202543

Suppliers and Packaging for NDA: 202543

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM IN SODIUM CHLORIDE
levetiracetam
INJECTABLE;IV (INFUSION) 202543 NDA Mylan Institutional LLC 67457-255 67457-255-10 10 BAG in 1 CARTON (67457-255-10) > 100 mL in 1 BAG (67457-255-00)
LEVETIRACETAM IN SODIUM CHLORIDE
levetiracetam
INJECTABLE;IV (INFUSION) 202543 NDA Mylan Institutional LLC 67457-265 67457-265-10 10 BAG in 1 CARTON (67457-265-10) > 100 mL in 1 BAG (67457-265-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength500MG/100ML (5MG/ML)
Approval Date:Nov 9, 2011TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength1000MG/100ML (10MG/ML)
Approval Date:Nov 9, 2011TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength1500MG/100ML (15MG/ML)
Approval Date:Nov 9, 2011TE:APRLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Baxter
Colorcon
Cerilliant
Teva
Medtronic
Fuji
AstraZeneca
UBS
Queensland Health

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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