Details for New Drug Application (NDA): 078926
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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 078926
Tradename: | GABAPENTIN |
Applicant: | Zydus Pharms Usa Inc |
Ingredient: | gabapentin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078926
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078926
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | gabapentin | TABLET;ORAL | 078926 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-611 | 43063-611-90 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-611-90) |
GABAPENTIN | gabapentin | TABLET;ORAL | 078926 | ANDA | A-S Medication Solutions | 50090-3915 | 50090-3915-0 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-3915-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Feb 11, 2011 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Feb 11, 2011 | TE: | AB1 | RLD: | No |
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