Product Details for ANDA 204963
DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
10MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
75MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
150MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 001
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 001
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
25MG
Marketing Status: Prescription
Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 002
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 002
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 003
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 003
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
75MG
Marketing Status: Prescription
Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 004
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 004
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 005
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 005
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
150MG
Marketing Status: Prescription
Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 006
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: DESIPRAMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204963
Product Number: 006
Approval Date: Dec 26, 2017
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information