Product Details for NDA 022411
OLEPTRO (TRAZODONE HYDROCHLORIDE)
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: OLEPTRO
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; 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Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022411
Product Number: 001
Approval Date: Feb 2, 2010
Applicant Holder Full Name: ANGELINI PHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
OLEPTRO (TRAZODONE HYDROCHLORIDE)
Proprietary Name: OLEPTRO
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; 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Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022411
Product Number: 001
Approval Date: Feb 2, 2010
Applicant Holder Full Name: ANGELINI PHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: OLEPTRO
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; 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Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022411
Product Number: 002
Approval Date: Feb 2, 2010
Applicant Holder Full Name: ANGELINI PHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: OLEPTRO
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; 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Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022411
Product Number: 002
Approval Date: Feb 2, 2010
Applicant Holder Full Name: ANGELINI PHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information