Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078421

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VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
EQ 37.5MG BASE
Marketing Status: Prescription

Active Ingredient: VENLAFAXINE HYDROCHLORIDE
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 37.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078421
Product Number: 001
Approval Date: May 6, 2011
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
EQ 75MG BASE
Marketing Status: Prescription

Active Ingredient: VENLAFAXINE HYDROCHLORIDE
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078421
Product Number: 002
Approval Date: May 6, 2011
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
EQ 150MG BASE
Marketing Status: Prescription

Active Ingredient: VENLAFAXINE HYDROCHLORIDE
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078421
Product Number: 003
Approval Date: May 6, 2011
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information