Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 011836

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PRESAMINE (IMIPRAMINE HYDROCHLORIDE)
10MG
Marketing Status: Discontinued

Active Ingredient: IMIPRAMINE HYDROCHLORIDE
Proprietary Name: PRESAMINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N011836
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRESAMINE (IMIPRAMINE HYDROCHLORIDE)
25MG
Marketing Status: Discontinued

Active Ingredient: IMIPRAMINE HYDROCHLORIDE
Proprietary Name: PRESAMINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N011836
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRESAMINE (IMIPRAMINE HYDROCHLORIDE)
50MG
Marketing Status: Discontinued

Active Ingredient: IMIPRAMINE HYDROCHLORIDE
Proprietary Name: PRESAMINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N011836
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information