Details for New Drug Application (NDA): 020882
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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 are twenty-nine drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
The generic ingredient in NEURONTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Eighty-two 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 | Parke-Davis Div of Pfizer Inc | 0071-0401 | 0071-0401-24 | 100 TABLET, FILM COATED in 1 BOTTLE (0071-0401-24) |
| NEURONTIN | gabapentin | TABLET;ORAL | 020882 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0513 | 0071-0513-24 | 100 TABLET, FILM COATED in 1 BOTTLE (0071-0513-24) |
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 | ||||
Expired US Patents for NDA 020882
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | NEURONTIN | gabapentin | TABLET;ORAL | 020882-002 | Oct 9, 1998 | 5,084,479*PED | ⤷ Get Started Free |
| Viatris | NEURONTIN | gabapentin | TABLET;ORAL | 020882-001 | Oct 9, 1998 | 4,087,544*PED | ⤷ Get Started Free |
| Viatris | NEURONTIN | gabapentin | TABLET;ORAL | 020882-002 | Oct 9, 1998 | 6,054,482*PED | ⤷ Get Started Free |
| Viatris | NEURONTIN | gabapentin | TABLET;ORAL | 020882-002 | Oct 9, 1998 | 4,894,476*PED | ⤷ Get Started Free |
| Viatris | NEURONTIN | gabapentin | TABLET;ORAL | 020882-001 | Oct 9, 1998 | 6,054,482*PED | ⤷ Get Started Free |
| Viatris | NEURONTIN | gabapentin | TABLET;ORAL | 020882-002 | Oct 9, 1998 | 4,087,544*PED | ⤷ Get Started Free |
| Viatris | NEURONTIN | gabapentin | TABLET;ORAL | 020882-001 | Oct 9, 1998 | 5,084,479*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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