Details for New Drug Application (NDA): 022525
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NDA 022525 describes NAMENDA XR, which is a drug marketed by Abbvie and is included in one NDA. There is one patent protecting this drug and four Paragraph IV challenges. Additional details are available on the NAMENDA XR profile page.
The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.
The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.
Summary for 022525
| Tradename: | NAMENDA XR |
| Applicant: | Abbvie |
| Ingredient: | memantine hydrochloride |
| Patents: | 1 |
Medical Subject Heading (MeSH) Categories for 022525
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 21, 2010 | TE: | RLD: | Yes | |||||
| Patent: | 8,039,009*PED | Patent Expiration: | Sep 24, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 14MG | ||||
| Approval Date: | Jun 21, 2010 | TE: | RLD: | Yes | |||||
| Patent: | 8,039,009*PED | Patent Expiration: | Sep 24, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 21MG | ||||
| Approval Date: | Jun 21, 2010 | TE: | RLD: | Yes | |||||
| Patent: | 8,039,009*PED | Patent Expiration: | Sep 24, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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