Product Details for NDA 022525
NAMENDA XR (MEMANTINE HYDROCHLORIDE)
7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
14MG
Marketing Status: Discontinued
21MG
Marketing Status: Discontinued
28MG
Marketing Status: Discontinued
7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022525
Product Number: 001
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
NAMENDA XR (MEMANTINE HYDROCHLORIDE)
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022525
Product Number: 001
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
14MG
Marketing Status: Discontinued
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 14MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022525
Product Number: 002
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
NAMENDA XR (MEMANTINE HYDROCHLORIDE)
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 14MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022525
Product Number: 002
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
21MG
Marketing Status: Discontinued
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 21MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022525
Product Number: 003
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
NAMENDA XR (MEMANTINE HYDROCHLORIDE)
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 21MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022525
Product Number: 003
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
28MG
Marketing Status: Discontinued
Active Ingredient: MEMANTINE HYDROCHLORIDE
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 28MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022525
Product Number: 004
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: NAMENDA XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 28MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022525
Product Number: 004
Approval Date: Jun 21, 2010
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information