Details for New Drug Application (NDA): 020844
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NDA 020844 describes TOPAMAX SPRINKLE, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the TOPAMAX SPRINKLE profile page.
The generic ingredient in TOPAMAX SPRINKLE is topiramate. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.
The generic ingredient in TOPAMAX SPRINKLE is topiramate. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 020844
| Tradename: | TOPAMAX SPRINKLE |
| Applicant: | Janssen Pharms |
| Ingredient: | topiramate |
| Patents: | 0 |
Pharmacology for NDA: 020844
| 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: 020844
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOPAMAX | topiramate | CAPSULE;ORAL | 020844 | NDA | Janssen Pharmaceuticals, Inc. | 50458-645 | 50458-645-65 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65) |
| TOPAMAX SPRINKLE | topiramate | CAPSULE;ORAL | 020844 | NDA | Janssen Pharmaceuticals, Inc. | 50458-645 | 50458-645-65 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
| Approval Date: | Oct 26, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 26, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 26, 1998 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020844
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | TOPAMAX | topiramate | CAPSULE;ORAL | 020844-002 | Oct 26, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | TOPAMAX SPRINKLE | topiramate | CAPSULE;ORAL | 020844-003 | Oct 26, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | TOPAMAX SPRINKLE | topiramate | CAPSULE;ORAL | 020844-003 | Oct 26, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | TOPAMAX | topiramate | CAPSULE;ORAL | 020844-001 | Oct 26, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | TOPAMAX | topiramate | CAPSULE;ORAL | 020844-002 | Oct 26, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | TOPAMAX | topiramate | CAPSULE;ORAL | 020844-001 | Oct 26, 1998 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | TOPAMAX SPRINKLE | topiramate | CAPSULE;ORAL | 020844-003 | Oct 26, 1998 | ⤷ Subscribe | ⤷ Subscribe |
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