Details for New Drug Application (NDA): 021487
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The generic ingredient in NAMENDA is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.
Summary for 021487
Tradename: | NAMENDA |
Applicant: | Abbvie |
Ingredient: | memantine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021487
Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 021487
Suppliers and Packaging for NDA: 021487
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487 | NDA | Allergan, Inc. | 0456-3200 | 0456-3200-14 | 1 KIT in 1 BLISTER PACK (0456-3200-14) |
NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 0591-3870 | 0591-3870-44 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0591-3870-44) / 10 TABLET in 1 BLISTER PACK (0591-3870-45) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 16, 2003 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 16, 2003 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021487
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-001 | Oct 16, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-002 | Oct 16, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-001 | Oct 16, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-002 | Oct 16, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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