Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090178

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GALANTAMINE HYDROBROMIDE (GALANTAMINE HYDROBROMIDE)
EQ 8MG BASE
Marketing Status: Prescription

Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: GALANTAMINE HYDROBROMIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090178
Product Number: 001
Approval Date: Feb 2, 2011
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

GALANTAMINE HYDROBROMIDE (GALANTAMINE HYDROBROMIDE)
EQ 16MG BASE
Marketing Status: Prescription

Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: GALANTAMINE HYDROBROMIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 16MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090178
Product Number: 002
Approval Date: Feb 2, 2011
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

GALANTAMINE HYDROBROMIDE (GALANTAMINE HYDROBROMIDE)
EQ 24MG BASE
Marketing Status: Prescription

Active Ingredient: GALANTAMINE HYDROBROMIDE
Proprietary Name: GALANTAMINE HYDROBROMIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 24MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090178
Product Number: 003
Approval Date: Feb 2, 2011
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information