Details for New Drug Application (NDA): 206439
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NDA 206439 describes NAMZARIC, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NAMZARIC profile page.
The generic ingredient in NAMZARIC is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
The generic ingredient in NAMZARIC is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
Summary for 206439
| Tradename: | NAMZARIC |
| Applicant: | Abbvie |
| Ingredient: | donepezil hydrochloride; memantine hydrochloride |
| Patents: | 2 |
Pharmacology for NDA: 206439
| Mechanism of Action | Cholinesterase Inhibitors NMDA Receptor Antagonists |
Suppliers and Packaging for NDA: 206439
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAMZARIC | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206439 | NDA | Allergan, Inc. | 0456-1207 | 0456-1207-30 | 30 CAPSULE in 1 BOTTLE (0456-1207-30) |
| NAMZARIC | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206439 | NDA | Allergan, Inc. | 0456-1214 | 0456-1214-11 | 10 CAPSULE in 1 BLISTER PACK (0456-1214-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG;14MG | ||||
| Approval Date: | Dec 23, 2014 | TE: | AB | RLD: | Yes | ||||
| Patent: | 8,039,009*PED | Patent Expiration: | Sep 24, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 8,058,291 | Patent Expiration: | Dec 5, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG;28MG | ||||
| Approval Date: | Dec 23, 2014 | TE: | AB | RLD: | Yes | ||||
| Patent: | 8,039,009*PED | Patent Expiration: | Sep 24, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 206439
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