Product Details for NDA 016792
SURMONTIL (TRIMIPRAMINE MALEATE)
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRIMIPRAMINE MALEATE
Proprietary Name: SURMONTIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016792
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SURMONTIL (TRIMIPRAMINE MALEATE)
Proprietary Name: SURMONTIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016792
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
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EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: TRIMIPRAMINE MALEATE
Proprietary Name: SURMONTIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016792
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SURMONTIL (TRIMIPRAMINE MALEATE)
Proprietary Name: SURMONTIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG 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: N016792
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
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: TRIMIPRAMINE MALEATE
Proprietary Name: SURMONTIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG 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: N016792
Product Number: 003
Approval Date: Sep 15, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SURMONTIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG 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: N016792
Product Number: 003
Approval Date: Sep 15, 1982
Applicant Holder Full Name: ODYSSEY PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information