Details for New Drug Application (NDA): 090705
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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 090705
Tradename: | GABAPENTIN |
Applicant: | Invagen Pharms |
Ingredient: | gabapentin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090705
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 090705
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | gabapentin | CAPSULE;ORAL | 090705 | ANDA | Medsource Pharmaceuticals | 45865-498 | 45865-498-30 | 30 CAPSULE in 1 BOTTLE (45865-498-30) |
GABAPENTIN | gabapentin | CAPSULE;ORAL | 090705 | ANDA | Medsource Pharmaceuticals | 45865-498 | 45865-498-60 | 60 CAPSULE in 1 BOTTLE (45865-498-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 30, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Dec 30, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 400MG | ||||
Approval Date: | Dec 30, 2009 | TE: | AB | RLD: | No |
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