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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 is included in one NDA. It is available from one supplier. 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-four drug master file entries for this compound. Ninety suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the levetiracetam profile page.

Summary for NDA: 202543

Tradename:
LEVETIRACETAM IN SODIUM CHLORIDE
Applicant:
Hq Speciality Pharma
Ingredient:
levetiracetam
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:RLD:Yes

Summary for product number 002

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

Summary for product number 003

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


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