Details for New Drug Application (NDA): 021129
✉ Email this page to a colleague
The generic ingredient in NEURONTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Eighty-four 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 | ||||
Expired US Patents for NDA 021129
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | NEURONTIN | gabapentin | SOLUTION;ORAL | 021129-001 | Mar 2, 2000 | ⤷ Start Trial | ⤷ Start Trial |
| Viatris | NEURONTIN | gabapentin | SOLUTION;ORAL | 021129-001 | Mar 2, 2000 | ⤷ Start Trial | ⤷ Start Trial |
| Viatris | NEURONTIN | gabapentin | SOLUTION;ORAL | 021129-001 | Mar 2, 2000 | ⤷ Start Trial | ⤷ Start Trial |
| Viatris | NEURONTIN | gabapentin | SOLUTION;ORAL | 021129-001 | Mar 2, 2000 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
