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Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207160

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NDA 207160 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 207160
Tradename:LEVETIRACETAM IN SODIUM CHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:levetiracetam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207160
Suppliers and Packaging for NDA: 207160
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;IV (INFUSION) 207160 ANDA AuroMedics Pharma LLC 55150-246 55150-246-47 10 POUCH in 1 CARTON (55150-246-47) > 1 BAG in 1 POUCH > 100 mL in 1 BAG
LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;IV (INFUSION) 207160 ANDA AuroMedics Pharma LLC 55150-247 55150-247-47 10 POUCH in 1 CARTON (55150-247-47) > 1 BAG in 1 POUCH > 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength500MG/100ML (5MG/ML)
Approval Date:Jan 4, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength1000MG/100ML (10MG/ML)
Approval Date:Jan 4, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength1500MG/100ML (15MG/ML)
Approval Date:Jan 4, 2017TE:APRLD:No

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