Details for New Drug Application (NDA): 090843
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The generic ingredient in LEVETIRACETAM 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 090843
Tradename: | LEVETIRACETAM |
Applicant: | Accord Hlthcare |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090843
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 090843
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | TABLET;ORAL | 090843 | ANDA | Accord Healthcare Inc. | 16729-064 | 16729-064-16 | 500 TABLET, FILM COATED in 1 BOTTLE (16729-064-16) |
LEVETIRACETAM | levetiracetam | TABLET;ORAL | 090843 | ANDA | Accord Healthcare Inc. | 16729-064 | 16729-064-29 | 120 TABLET, FILM COATED in 1 BOTTLE (16729-064-29) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Feb 14, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Feb 14, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Feb 14, 2011 | TE: | AB | RLD: | No |
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