Details for New Drug Application (NDA): 008278
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NDA 008278 describes REGITINE, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the REGITINE profile page.
The generic ingredient in REGITINE is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.
The generic ingredient in REGITINE is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.
Summary for 008278
| Tradename: | REGITINE |
| Applicant: | Novartis |
| Ingredient: | phentolamine mesylate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 008278
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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