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Details for New Drug Application (NDA): 200651
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The generic ingredient in GABAPENTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 200651
Tradename: | GABAPENTIN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | gabapentin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 200651
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 200651
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | gabapentin | TABLET;ORAL | 200651 | ANDA | Major Pharmaceuticals | 0904-6823 | 0904-6823-61 | 100 BLISTER PACK in 1 CARTON (0904-6823-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK |
GABAPENTIN | gabapentin | TABLET;ORAL | 200651 | ANDA | NorthStar Rx LLC | 16714-330 | 16714-330-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-330-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Oct 6, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Oct 6, 2011 | TE: | AB | RLD: | No |
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