Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 014399

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NORPRAMIN (DESIPRAMINE HYDROCHLORIDE)
10MG
Marketing Status: Prescription

Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: NORPRAMIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N014399
Product Number: 007
Approval Date: Feb 11, 1982
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NORPRAMIN (DESIPRAMINE HYDROCHLORIDE)
25MG
Marketing Status: Prescription

Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: NORPRAMIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N014399
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NORPRAMIN (DESIPRAMINE HYDROCHLORIDE)
50MG
Marketing Status: Prescription

Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: NORPRAMIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N014399
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NORPRAMIN (DESIPRAMINE HYDROCHLORIDE)
75MG
Marketing Status: Prescription

Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: NORPRAMIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N014399
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NORPRAMIN (DESIPRAMINE HYDROCHLORIDE)
100MG
Marketing Status: Prescription

Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: NORPRAMIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N014399
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NORPRAMIN (DESIPRAMINE HYDROCHLORIDE)
150MG
Marketing Status: Prescription

Active Ingredient: DESIPRAMINE HYDROCHLORIDE
Proprietary Name: NORPRAMIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N014399
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information