Details for New Drug Application (NDA): 077661
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The generic ingredient in GABAPENTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 077661
Tradename: | GABAPENTIN |
Applicant: | Rubicon |
Ingredient: | gabapentin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077661
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 077661
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | gabapentin | TABLET;ORAL | 077661 | ANDA | Advagen Pharma Ltd | 72888-131 | 72888-131-00 | 1000 TABLET in 1 BOTTLE (72888-131-00) |
GABAPENTIN | gabapentin | TABLET;ORAL | 077661 | ANDA | Advagen Pharma Ltd | 72888-131 | 72888-131-01 | 100 TABLET in 1 BOTTLE (72888-131-01) |
Profile for product number 004
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Sep 13, 2006 | TE: | AB1 | RLD: | No |
Profile for product number 005
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Sep 13, 2006 | TE: | AB1 | RLD: | No |
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