Product Details for NDA 022104
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
EQ 37.5MG BASE
Marketing Status: Prescription
EQ 75MG BASE
Marketing Status: Prescription
EQ 150MG BASE
Marketing Status: Prescription
EQ 225MG BASE
Marketing Status: Prescription
EQ 37.5MG BASE
Marketing Status: Prescription
Active Ingredient: VENLAFAXINE HYDROCHLORIDE
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 37.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022104
Product Number: 001
Approval Date: May 20, 2008
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 37.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022104
Product Number: 001
Approval Date: May 20, 2008
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 75MG BASE
Marketing Status: Prescription
Active Ingredient: VENLAFAXINE HYDROCHLORIDE
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022104
Product Number: 002
Approval Date: May 20, 2008
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022104
Product Number: 002
Approval Date: May 20, 2008
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: VENLAFAXINE HYDROCHLORIDE
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022104
Product Number: 003
Approval Date: May 20, 2008
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022104
Product Number: 003
Approval Date: May 20, 2008
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 225MG BASE
Marketing Status: Prescription
Active Ingredient: VENLAFAXINE HYDROCHLORIDE
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 225MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022104
Product Number: 004
Approval Date: May 20, 2008
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: VENLAFAXINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 225MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022104
Product Number: 004
Approval Date: May 20, 2008
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status: Prescription
Patent and Exclusivity Information