Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 071196

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TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
100MG
Marketing Status: Prescription

Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: TRAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A071196
Product Number: 001
Approval Date: Mar 25, 1987
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
150MG
Marketing Status: Prescription

Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: TRAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A071196
Product Number: 002
Approval Date: Apr 26, 1999
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
300MG
Marketing Status: Prescription

Active Ingredient: TRAZODONE HYDROCHLORIDE
Proprietary Name: TRAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A071196
Product Number: 003
Approval Date: Apr 26, 1999
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information