Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021615

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RAZADYNE ER (GALANTAMINE HYDROBROMIDE)
EQ 8MG BASE
Marketing Status: Discontinued

Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: RAZADYNE ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 8MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021615
Product Number: 001
Approval Date: Apr 1, 2005
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RAZADYNE ER (GALANTAMINE HYDROBROMIDE)
EQ 16MG BASE
Marketing Status: Discontinued

Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: RAZADYNE ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 16MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021615
Product Number: 002
Approval Date: Apr 1, 2005
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

RAZADYNE ER (GALANTAMINE HYDROBROMIDE)
EQ 24MG BASE
Marketing Status: Discontinued

Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: RAZADYNE ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 24MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021615
Product Number: 003
Approval Date: Apr 1, 2005
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information