Details for New Drug Application (NDA): 090858
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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 090858
Tradename: | GABAPENTIN |
Applicant: | Alkem |
Ingredient: | gabapentin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090858
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 090858
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | gabapentin | CAPSULE;ORAL | 090858 | ANDA | Major Pharmaceuticals | 0904-6665 | 0904-6665-61 | 100 BLISTER PACK in 1 CARTON (0904-6665-61) / 1 CAPSULE in 1 BLISTER PACK |
GABAPENTIN | gabapentin | CAPSULE;ORAL | 090858 | ANDA | Major Pharmaceuticals | 0904-6666 | 0904-6666-61 | 100 BLISTER PACK in 1 CARTON (0904-6666-61) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 17, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Dec 17, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 400MG | ||||
Approval Date: | Dec 17, 2010 | TE: | AB | RLD: | No |
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