Details for New Drug Application (NDA): 205122
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NDA 205122 describes QUDEXY XR, which is a drug marketed by Upsher Smith Labs and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the QUDEXY XR profile page.
The generic ingredient in QUDEXY XR 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 QUDEXY XR 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 205122
| Tradename: | QUDEXY XR |
| Applicant: | Upsher Smith Labs |
| Ingredient: | topiramate |
| Patents: | 5 |
Pharmacology for NDA: 205122
| 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: 205122
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122 | NDA | Upsher-Smith Laboratories, LLC | 0245-1071 | 0245-1071-30 | 1 BOTTLE in 1 CARTON (0245-1071-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE |
| QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122 | NDA | Upsher-Smith Laboratories, LLC | 0245-1071 | 0245-1071-90 | 1 BOTTLE in 1 CARTON (0245-1071-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
| Approval Date: | Mar 11, 2014 | TE: | AB2 | RLD: | Yes | ||||
| Patent: | 10,363,224 | Patent Expiration: | Mar 19, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SEIZURES | ||||||||
| Patent: | 8,652,527 | Patent Expiration: | Mar 19, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,889,190 | Patent Expiration: | Mar 19, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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