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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "022525."



Active Ingredient: MEMANTINE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: NAMENDA XR
Applicant: FOREST LABS
Strength: 7MG
Application Number: N022525
Product Number: 001
Approval Date: Jun 21, 2010
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: MEMANTINE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: NAMENDA XR
Applicant: FOREST LABS
Strength: 14MG
Application Number: N022525
Product Number: 002
Approval Date: Jun 21, 2010
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: MEMANTINE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: NAMENDA XR
Applicant: FOREST LABS
Strength: 21MG
Application Number: N022525
Product Number: 003
Approval Date: Jun 21, 2010
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: MEMANTINE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: NAMENDA XR
Applicant: FOREST LABS
Strength: 28MG
Application Number: N022525
Product Number: 004
Approval Date: Jun 21, 2010
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through November 2014
Patent and Generic Drug Product Data Last Updated December 17, 2014

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