Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018207

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DESYREL (TRAZODONE HYDROCHLORIDE)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: DESYREL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018207
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DESYREL (TRAZODONE HYDROCHLORIDE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: DESYREL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018207
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DESYREL (TRAZODONE HYDROCHLORIDE)
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: DESYREL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018207
Product Number: 003
Approval Date: Mar 25, 1985
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DESYREL (TRAZODONE HYDROCHLORIDE)
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: DESYREL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG **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: N018207
Product Number: 004
Approval Date: Nov 7, 1988
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information