Product Details for NDA 021615
RAZADYNE ER (GALANTAMINE HYDROBROMIDE)
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: RAZADYNE ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: 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)
Proprietary Name: RAZADYNE ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021615
Product Number: 001
Approval Date: Apr 1, 2005
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: RAZADYNE ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: 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)
Proprietary Name: RAZADYNE ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 16MG BASE **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: N021615
Product Number: 002
Approval Date: Apr 1, 2005
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: RAZADYNE ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 24MG BASE **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: N021615
Product Number: 003
Approval Date: Apr 1, 2005
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: RAZADYNE ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 24MG BASE **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: N021615
Product Number: 003
Approval Date: Apr 1, 2005
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information