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Details for New Drug Application (NDA): 020235
NDA 020235 describes NEURONTIN, which is a drug marketed by Pfizer Pharms and Parke Davis and is included in three NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the NEURONTIN profile page.
The generic ingredient in NEURONTIN is gabapentin. There are twenty-eight drug master file entries for this compound. One hundred and eleven 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-eight drug master file entries for this compound. One hundred and eleven 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 |
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
| Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-001 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
| Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-003 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
| Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-003 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
| Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-003 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
| Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-002 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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