Details for New Drug Application (NDA): 020235
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The generic ingredient in NEURONTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Seventy-eight 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 | 0071-0803 | 0071-0803-24 | 100 CAPSULE in 1 BOTTLE (0071-0803-24) |
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) |
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 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-001 | Dec 30, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-001 | Dec 30, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-003 | Dec 30, 1993 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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