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Details for New Drug Application (NDA): 020235
The generic ingredient in NEURONTIN is gabapentin. There are twenty-eight drug master file entries for this compound. One hundred and eight suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 020235
Tradename: | NEURONTIN |
Applicant: | Pfizer Pharms |
Ingredient: | gabapentin |
Patents: | 0 |
Therapeutic Class: | Anticonvulsants |
Formulation / Manufacturing: | see details |
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 | N | 0071-0803-24 |
NEURONTIN | gabapentin | CAPSULE;ORAL | 020235 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0805 | N | 0071-0805-40 |
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 |
---|---|---|---|---|---|---|---|
Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-001 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-001 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-002 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-001 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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