Details for New Drug Application (NDA): 201157
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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 201157
Tradename: | LEVETIRACETAM |
Applicant: | Pharm Assoc |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201157
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 201157
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | SOLUTION;ORAL | 201157 | ANDA | PAI Holdings, LLC | 0121-0799 | 0121-0799-16 | 473 mL in 1 BOTTLE (0121-0799-16) |
LEVETIRACETAM | levetiracetam | SOLUTION;ORAL | 201157 | ANDA | PAI Holdings, LLC | 0121-1598 | 0121-1598-20 | 2 TRAY in 1 CASE (0121-1598-20) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1598-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/ML | ||||
Approval Date: | Jun 4, 2015 | TE: | AA | RLD: | No |
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