Product Details for ANDA 210653
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
75MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
Active Ingredient: CLOMIPRAMINE HYDROCHLORIDE
Proprietary Name: CLOMIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210653
Product Number: 001
Approval Date: Apr 3, 2020
Applicant Holder Full Name: TULEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
Proprietary Name: CLOMIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210653
Product Number: 001
Approval Date: Apr 3, 2020
Applicant Holder Full Name: TULEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: CLOMIPRAMINE HYDROCHLORIDE
Proprietary Name: CLOMIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210653
Product Number: 002
Approval Date: Apr 3, 2020
Applicant Holder Full Name: TULEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
Proprietary Name: CLOMIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210653
Product Number: 002
Approval Date: Apr 3, 2020
Applicant Holder Full Name: TULEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
75MG
Marketing Status: Prescription
Active Ingredient: CLOMIPRAMINE HYDROCHLORIDE
Proprietary Name: CLOMIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210653
Product Number: 003
Approval Date: Apr 3, 2020
Applicant Holder Full Name: TULEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: CLOMIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210653
Product Number: 003
Approval Date: Apr 3, 2020
Applicant Holder Full Name: TULEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information