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Generated: November 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206880

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NDA 206880 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 five 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-seven suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 206880
Tradename:LEVETIRACETAM IN SODIUM CHLORIDE
Applicant:Gland Pharma Ltd
Ingredient:levetiracetam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206880
Suppliers and Packaging for NDA: 206880
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;IV (INFUSION) 206880 ANDA Dr.Reddy's Laboratories Inc 43598-635 43598-635-10 10 BAG in 1 CARTON (43598-635-10) > 100 mL in 1 BAG (43598-635-52)
LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;IV (INFUSION) 206880 ANDA Dr.Reddy's Laboratories Inc 43598-636 43598-636-10 10 BAG in 1 CARTON (43598-636-10) > 100 mL in 1 BAG (43598-636-52)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength500MG/100ML (5MG/ML)
Approval Date:Oct 25, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength1000MG/100ML (10MG/ML)
Approval Date:Oct 25, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength1500MG/100ML (15MG/ML)
Approval Date:Oct 25, 2017TE:APRLD:No

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