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 three 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. Eighty-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
The generic ingredient in SPRITAM is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-six 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: | 3 |
Pharmacology for NDA: 207958
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 250MG | ||||
| Approval Date: | Jul 31, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 11,160,786 | Patent Expiration: | Mar 14, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,339,489 | Patent Expiration: | Mar 14, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF ADMINISTERING LEVETIRACETAM | ||||||||
| Patent: | 9,669,009 | Patent Expiration: | Mar 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF ADMINISTERING LEVETIRACETAM | ||||||||
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 | 207958-002 | Jul 31, 2015 | 9,463,160 | ⤷ Subscribe |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-004 | Jul 31, 2015 | 6,471,992 | ⤷ Subscribe |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-003 | Jul 31, 2015 | 6,471,992 | ⤷ Subscribe |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-003 | Jul 31, 2015 | 9,463,160 | ⤷ Subscribe |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-001 | Jul 31, 2015 | 6,471,992 | ⤷ Subscribe |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-004 | Jul 31, 2015 | 9,463,160 | ⤷ Subscribe |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-001 | Jul 31, 2015 | 9,463,160 | ⤷ Subscribe |
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