Product Details for ANDA 078898
GALANTAMINE HYDROBROMIDE (GALANTAMINE HYDROBROMIDE)
EQ 4MG BASE
Marketing Status: Prescription
EQ 8MG BASE
Marketing Status: Prescription
EQ 12MG BASE
Marketing Status: Prescription
EQ 4MG BASE
Marketing Status: Prescription
Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: GALANTAMINE HYDROBROMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078898
Product Number: 001
Approval Date: Feb 17, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
GALANTAMINE HYDROBROMIDE (GALANTAMINE HYDROBROMIDE)
Proprietary Name: GALANTAMINE HYDROBROMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078898
Product Number: 001
Approval Date: Feb 17, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 8MG BASE
Marketing Status: Prescription
Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: GALANTAMINE HYDROBROMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078898
Product Number: 002
Approval Date: Feb 17, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
GALANTAMINE HYDROBROMIDE (GALANTAMINE HYDROBROMIDE)
Proprietary Name: GALANTAMINE HYDROBROMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078898
Product Number: 002
Approval Date: Feb 17, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 12MG BASE
Marketing Status: Prescription
Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: GALANTAMINE HYDROBROMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078898
Product Number: 003
Approval Date: Feb 17, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: GALANTAMINE HYDROBROMIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078898
Product Number: 003
Approval Date: Feb 17, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information