Details for New Drug Application (NDA): 216492
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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 216492
Tradename: | GABAPENTIN |
Applicant: | Rubicon |
Ingredient: | gabapentin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216492
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 216492
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | gabapentin | SOLUTION;ORAL | 216492 | ANDA | Advagen Pharma Ltd | 72888-104 | 72888-104-25 | 470 mL in 1 BOTTLE (72888-104-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 250MG/5ML | ||||
Approval Date: | Jan 18, 2023 | TE: | AA | RLD: | No |
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