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Details for New Drug Application (NDA): 200651
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NDA 200651 describes GABAPENTIN, which is a drug marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cspc Ouyi, Epic Pharma Llc, Granules India Ltd, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, Tris Pharma Inc, Alkem Labs Ltd, Apotex Inc, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Rubicon, Teva, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in forty-nine NDAs. It is available from seventy-nine suppliers. Additional details are available on the GABAPENTIN profile page.
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.
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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