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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 008278

REGITINE (PHENTOLAMINE MESYLATE)
5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PHENTOLAMINE MESYLATE
Proprietary Name: REGITINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N008278
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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