Product Details for NDA 019839
ZOLOFT (SERTRALINE HYDROCHLORIDE)
EQ 25MG BASE
Marketing Status: Prescription
EQ 50MG BASE
Marketing Status: Prescription
EQ 100MG BASE
Marketing Status: Prescription
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019839
Product Number: 005
Approval Date: Mar 6, 1996
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ZOLOFT (SERTRALINE HYDROCHLORIDE)
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019839
Product Number: 005
Approval Date: Mar 6, 1996
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019839
Product Number: 001
Approval Date: Dec 30, 1991
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ZOLOFT (SERTRALINE HYDROCHLORIDE)
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019839
Product Number: 001
Approval Date: Dec 30, 1991
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019839
Product Number: 002
Approval Date: Dec 30, 1991
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ZOLOFT (SERTRALINE HYDROCHLORIDE)
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019839
Product Number: 002
Approval Date: Dec 30, 1991
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019839
Product Number: 003
Approval Date: Dec 30, 1991
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZOLOFT (SERTRALINE HYDROCHLORIDE)
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019839
Product Number: 003
Approval Date: Dec 30, 1991
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019839
Product Number: 004
Approval Date: Dec 30, 1991
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019839
Product Number: 004
Approval Date: Dec 30, 1991
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Discontinued
Patent and Exclusivity Information