Details for New Drug Application (NDA): 078787
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NDA 078787 describes GABAPENTIN, which is a drug marketed by Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Granules, Hikma, Invagen Pharms, Ipca Labs Ltd, Laurus, Marksans Pharma, Norvium Bioscience, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Acella Pharms Llc, Amneal Pharms, Annora Pharma, Belcher, Mission Pharmacal, Pai Holdings Pharm, Rubicon, Abon Pharms Llc, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Hikma Pharms, Humanwell, Invatech, Ivax Sub Teva Pharms, Lupin Ltd, Ranbaxy, Teva, Teva Pharms Usa, Zydus Pharms, and Zydus Pharms Usa Inc, and is included in sixty-six NDAs. It is available from seventy-five 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. Seventy-eight 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. Seventy-eight suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 078787
| Tradename: | GABAPENTIN |
| Applicant: | Aurobindo Pharma |
| Ingredient: | gabapentin |
| Patents: | 0 |
Pharmacology for NDA: 078787
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078787
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | gabapentin | CAPSULE;ORAL | 078787 | ANDA | NorthStar Rx LLC | 16714-661 | 16714-661-01 | 100 CAPSULE in 1 BOTTLE (16714-661-01) |
| GABAPENTIN | gabapentin | CAPSULE;ORAL | 078787 | ANDA | NorthStar Rx LLC | 16714-661 | 16714-661-02 | 500 CAPSULE in 1 BOTTLE (16714-661-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jan 31, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Jan 31, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 400MG | ||||
| Approval Date: | Jan 31, 2008 | TE: | AB | RLD: | No | ||||
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