Details for New Drug Application (NDA): 021129
NDA 021129 describes NEURONTIN, which is a drug marketed by Viatris and is included in three NDAs. It is available from three suppliers. Additional details are available on the NEURONTIN profile page.
The generic ingredient in NEURONTIN is gabapentin. There is one drug master file entry for this compound. Ninety suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
The generic ingredient in NEURONTIN is gabapentin. There is one drug master file entry for this compound. Ninety suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 021129
| Tradename: | NEURONTIN |
| Applicant: | Viatris |
| Ingredient: | gabapentin |
| Patents: | 0 |
Pharmacology for NDA: 021129
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 021129
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEURONTIN | gabapentin | SOLUTION;ORAL | 021129 | NDA | Parke-Davis Div of Pfizer Inc | 0071-2012 | 0071-2012-47 | 1 BOTTLE, PLASTIC in 1 CARTON (0071-2012-47) / 470 mL in 1 BOTTLE, PLASTIC |
| NEURONTIN | gabapentin | SOLUTION;ORAL | 021129 | NDA | Viatris Specialty LLC | 58151-290 | 58151-290-35 | 1 BOTTLE in 1 CARTON (58151-290-35) / 470 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 250MG/5ML | ||||
| Approval Date: | Mar 2, 2000 | TE: | AA | RLD: | Yes | ||||
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