Details for New Drug Application (NDA): 020882
NDA 020882 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 020882
| Tradename: | NEURONTIN |
| Applicant: | Viatris |
| Ingredient: | gabapentin |
| Patents: | 0 |
Pharmacology for NDA: 020882
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 020882
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEURONTIN | gabapentin | TABLET;ORAL | 020882 | NDA | Viatris Specialty LLC | 58151-284 | 58151-284-01 | 100 TABLET, FILM COATED in 1 BOTTLE (58151-284-01) |
| NEURONTIN | gabapentin | TABLET;ORAL | 020882 | NDA | Viatris Specialty LLC | 58151-285 | 58151-285-01 | 100 TABLET, FILM COATED in 1 BOTTLE (58151-285-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Oct 9, 1998 | TE: | AB1 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Oct 9, 1998 | TE: | AB1 | RLD: | Yes | ||||
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