Details for New Drug Application (NDA): 020505
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The generic ingredient in TOPAMAX is topiramate. There are twenty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 020505
Tradename: | TOPAMAX |
Applicant: | Janssen Pharms |
Ingredient: | topiramate |
Patents: | 0 |
Pharmacology for NDA: 020505
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 020505
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOPAMAX | topiramate | TABLET;ORAL | 020505 | NDA | Janssen Pharmaceuticals, Inc. | 50458-639 | 50458-639-65 | 60 TABLET, COATED in 1 BOTTLE (50458-639-65) |
TOPAMAX | topiramate | TABLET;ORAL | 020505 | NDA | Janssen Pharmaceuticals, Inc. | 50458-640 | 50458-640-65 | 60 TABLET, COATED in 1 BOTTLE (50458-640-65) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 24, 1996 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Dec 24, 1996 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Dec 24, 1996 | TE: | RLD: | No |
Expired US Patents for NDA 020505
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-004 | Dec 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-006 | Dec 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-001 | Dec 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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