Product Details for NDA 016774
SERENTIL (MESORIDAZINE BESYLATE)
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MESORIDAZINE BESYLATE
Proprietary Name: SERENTIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016774
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
SERENTIL (MESORIDAZINE BESYLATE)
Proprietary Name: SERENTIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016774
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MESORIDAZINE BESYLATE
Proprietary Name: SERENTIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016774
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
SERENTIL (MESORIDAZINE BESYLATE)
Proprietary Name: SERENTIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016774
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MESORIDAZINE BESYLATE
Proprietary Name: SERENTIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016774
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
SERENTIL (MESORIDAZINE BESYLATE)
Proprietary Name: SERENTIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016774
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MESORIDAZINE BESYLATE
Proprietary Name: SERENTIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016774
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SERENTIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016774
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information