Search results from the "OB_Rx" table for query on "021615."



Active Ingredient: GALANTAMINE HYDROBROMIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: RAZADYNE ER
Applicant: ORTHO MCNEIL JANSSEN
Strength: EQ 8MG BASE
Application Number: 021615
Product Number: 001
Approval Date: Apr 1, 2005
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: GALANTAMINE HYDROBROMIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: RAZADYNE ER
Applicant: ORTHO MCNEIL JANSSEN
Strength: EQ 16MG BASE
Application Number: 021615
Product Number: 002
Approval Date: Apr 1, 2005
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: GALANTAMINE HYDROBROMIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: RAZADYNE ER
Applicant: ORTHO MCNEIL JANSSEN
Strength: EQ 24MG BASE
Application Number: 021615
Product Number: 003
Approval Date: Apr 1, 2005
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
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:
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    Orange Book Data Updated Through October, 2009
    Patent and Generic Drug Product Data Last Updated: November 20, 2009