Details for New Drug Application (NDA): 078904
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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 078904
Tradename: | LEVETIRACETAM |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078904
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078904
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | TABLET;ORAL | 078904 | ANDA | Dr. Reddy's Laboratories Limited | 55111-248 | 55111-248-01 | 100 TABLET in 1 BOTTLE (55111-248-01) |
LEVETIRACETAM | levetiracetam | TABLET;ORAL | 078904 | ANDA | Dr. Reddy's Laboratories Limited | 55111-248 | 55111-248-05 | 500 TABLET in 1 BOTTLE (55111-248-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
Approval Date: | Jan 15, 2009 | TE: | AB | RLD: | No |
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