DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 200651
NDA 200651 describes GABAPENTIN, which is a drug marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Epic Pharma Llc, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro Pharm, Teva Pharms, Watson Labs, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, Taro, Tris Pharma Inc, Alkem Labs Ltd, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Mylan Pharms Inc, Ranbaxy, Teva, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in forty-seven NDAs. It is available from one hundred and seven suppliers. Additional details are available on the GABAPENTIN profile page.
The generic ingredient in GABAPENTIN is gabapentin. There are twenty-eight drug master file entries for this compound. One hundred and ten 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-eight drug master file entries for this compound. One hundred and ten 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 |
| Therapeutic Class: | Anticonvulsants |
| 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 | NorthStar Rx LLC | 16714-330 | N | 16714-330-01 |
| GABAPENTIN | gabapentin | TABLET;ORAL | 200651 | ANDA | NorthStar Rx LLC | 16714-330 | N | 16714-330-02 |
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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