Application Information

This drug has been submitted to the FDA under the reference 207958/001.

Names and composition

"SPRITAM" is the commercial name of a drug composed of LEVETIRACETAM.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
207958/001 SPRITAM LEVETIRACETAM TABLET, FOR SUSPENSION/ORAL 250MG
207958/002 SPRITAM LEVETIRACETAM TABLET, FOR SUSPENSION/ORAL 500MG
207958/003 SPRITAM LEVETIRACETAM TABLET, FOR SUSPENSION/ORAL 750MG
207958/004 SPRITAM LEVETIRACETAM TABLET, FOR SUSPENSION/ORAL 1GM

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
021035/001 KEPPRA LEVETIRACETAM TABLET/ORAL 250MG
021035/002 KEPPRA LEVETIRACETAM TABLET/ORAL 500MG
021035/003 KEPPRA LEVETIRACETAM TABLET/ORAL 750MG
021035/004 KEPPRA LEVETIRACETAM TABLET/ORAL 1GM
021505/001 KEPPRA LEVETIRACETAM SOLUTION/ORAL 100MG per ML
021872/001 KEPPRA LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
022285/001 KEPPRA XR LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
022285/002 KEPPRA XR LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
076919/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
076919/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
076919/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
076920/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
076920/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
076920/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
077319/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
077319/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
077319/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
077324/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
077324/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
077324/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
077324/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
077408/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
077408/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
077408/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078042/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078042/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078042/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078042/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
078101/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078101/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078101/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078101/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
078106/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078106/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078106/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078106/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
078154/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078154/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078154/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078234/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078234/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078234/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078526/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078526/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078526/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078582/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
078731/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078731/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078731/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078731/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
078774/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
078797/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
078797/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078797/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078797/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078858/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078858/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078858/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078858/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
078869/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078869/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078869/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078869/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
078904/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
078918/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078918/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
078960/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
078960/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078960/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078960/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078976/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
078993/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
078993/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
078993/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
078993/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
079042/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
079042/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
079042/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
079042/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
079063/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
079107/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
079120/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
090025/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
090028/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
090079/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
090187/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
090261/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
090263/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
090461/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
090484/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
090511/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
090511/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
090511/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
090511/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
090515/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
090515/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
090515/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
090515/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
090601/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
090754/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
090767/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
090767/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
090767/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
090767/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
090813/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
090843/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
090843/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
090843/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
090843/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
090876/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
090893/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
090906/001 ROWEEPRA LEVETIRACETAM TABLET/ORAL 500MG
090906/002 ROWEEPRA LEVETIRACETAM TABLET/ORAL 250MG
090906/003 ROWEEPRA LEVETIRACETAM TABLET/ORAL 750MG
090906/004 ROWEEPRA LEVETIRACETAM TABLET/ORAL 1GM
090981/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
090992/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
091093/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
091093/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
091261/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
091261/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
091285/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
091285/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
091291/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
091291/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
091338/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
091338/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
091360/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
091360/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
091399/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
091399/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
091430/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
091430/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
091485/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
091491/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
091491/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
091491/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
091491/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
091557/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
091557/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
091627/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
091668/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
091668/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
200475/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
200475/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
200475/003 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 1GM
201157/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
201293/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
201293/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
201293/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
201293/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
201464/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
201464/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
202095/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
202095/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
202143/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
202167/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
202167/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
202524/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
202524/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
202533/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
202533/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
202543/001 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 100ML (5MG per ML)
202543/002 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE/IV (INFUSION) 1000MG per 100ML (10MG per ML)
202543/003 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE/IV (INFUSION) 1500MG per 100ML (15MG per ML)
202869/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
202958/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 1GM
203052/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
203059/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
203059/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
203067/001 LEVETIRACETAM LEVETIRACETAM SOLUTION/ORAL 100MG per ML
203308/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
203468/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
203468/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
204312/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
204511/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
204511/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
204754/001 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 500MG
204754/002 LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE/ORAL 750MG
205102/001 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 250MG
205102/002 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 750MG
205102/003 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 1GM
205102/004 LEVETIRACETAM LEVETIRACETAM TABLET/ORAL 500MG
206838/001 LEVETIRACETAM LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 5ML (100MG per ML)
207160/001 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE/IV (INFUSION) 500MG per 100ML (5MG per ML)
207160/002 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE/IV (INFUSION) 1000MG per 100ML (10MG per ML)
207160/003 LEVETIRACETAM IN SODIUM CHLORIDE LEVETIRACETAM INJECTABLE/IV (INFUSION) 1500MG per 100ML (15MG per ML)
207958/001 SPRITAM LEVETIRACETAM TABLET, FOR SUSPENSION/ORAL 250MG
207958/002 SPRITAM LEVETIRACETAM TABLET, FOR SUSPENSION/ORAL 500MG
207958/003 SPRITAM LEVETIRACETAM TABLET, FOR SUSPENSION/ORAL 750MG
207958/004 SPRITAM LEVETIRACETAM TABLET, FOR SUSPENSION/ORAL 1GM

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