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Generated: December 15, 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 Aurobindo Pharma Ltd, Gland Pharma Ltd, and Hq Speciality Pharma, and is included in three NDAs. It is available from three 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. One hundred suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

Summary for 202543

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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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