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Generated: June 16, 2019

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Details for New Drug Application (NDA): 207958

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NDA 207958 describes SPRITAM, which is a drug marketed by Aprecia Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SPRITAM profile page.

The generic ingredient in SPRITAM is levetiracetam. There are thirty-five drug master file entries for this compound. Ninety-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 207958
Tradename:SPRITAM
Applicant:Aprecia Pharms
Ingredient:levetiracetam
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 207958
Suppliers and Packaging for NDA: 207958
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958 NDA Aprecia Pharmaceuticals, LLC 43485-101 43485-101-60 60 BLISTER PACK in 1 CARTON (43485-101-60) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-101-01)
SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958 NDA Aprecia Pharmaceuticals, LLC 43485-102 43485-102-60 60 BLISTER PACK in 1 CARTON (43485-102-60) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-102-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength250MG
Approval Date:Jul 31, 2015TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 14, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING LEVETIRACETAM
Patent:➤ Try a Free TrialPatent Expiration:Mar 14, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING LEVETIRACETAM
Patent:➤ Try a Free TrialPatent Expiration:Mar 14, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING LEVETIRACETAM UNDER FASTED CONDITIONS

Expired US Patents for NDA 207958

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-003 Jul 31, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-004 Jul 31, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-002 Jul 31, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-001 Jul 31, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-004 Jul 31, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-003 Jul 31, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Accenture

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