Details for New Drug Application (NDA): 020235
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 020235
| Tradename: | NEURONTIN |
| Applicant: | Viatris |
| Ingredient: | gabapentin |
| Patents: | 0 |
Pharmacology for NDA: 020235
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 020235
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEURONTIN | gabapentin | CAPSULE;ORAL | 020235 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0805 | 0071-0805-24 | 100 CAPSULE in 1 BOTTLE (0071-0805-24) |
| NEURONTIN | gabapentin | CAPSULE;ORAL | 020235 | NDA | Viatris Specialty LLC | 58151-281 | 58151-281-01 | 100 CAPSULE in 1 BOTTLE (58151-281-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 30, 1993 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Dec 30, 1993 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 400MG | ||||
| Approval Date: | Dec 30, 1993 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020235
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-002 | Dec 30, 1993 | ⤷ Start Trial | ⤷ Start Trial |
| Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-003 | Dec 30, 1993 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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