Product Details for ANDA 076671
SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
EQ 25MG BASE
Marketing Status: Discontinued
EQ 50MG BASE
Marketing Status: Discontinued
EQ 100MG BASE
Marketing Status: Discontinued
EQ 25MG BASE
Marketing Status: Discontinued
Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: SERTRALINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076671
Product Number: 001
Approval Date: Feb 6, 2007
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
Proprietary Name: SERTRALINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076671
Product Number: 001
Approval Date: Feb 6, 2007
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 50MG BASE
Marketing Status: Discontinued
Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: SERTRALINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076671
Product Number: 002
Approval Date: Feb 6, 2007
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
Proprietary Name: SERTRALINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076671
Product Number: 002
Approval Date: Feb 6, 2007
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 100MG BASE
Marketing Status: Discontinued
Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: SERTRALINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076671
Product Number: 003
Approval Date: Feb 6, 2007
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SERTRALINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076671
Product Number: 003
Approval Date: Feb 6, 2007
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information