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Last Updated: January 27, 2020

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Details for New Drug Application (NDA): 040235

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NDA 040235 describes PHENTOLAMINE MESYLATE, which is a drug marketed by Precision Dose Inc and West-ward Pharms Int and is included in two NDAs. It is available from three suppliers. Additional details are available on the PHENTOLAMINE MESYLATE profile page.

The generic ingredient in PHENTOLAMINE MESYLATE is phentolamine mesylate. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.
Summary for 040235
Tradename:PHENTOLAMINE MESYLATE
Applicant:West-ward Pharms Int
Ingredient:phentolamine mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040235
Mechanism of ActionAdrenergic alpha-Antagonists
Medical Subject Heading (MeSH) Categories for 040235
Suppliers and Packaging for NDA: 040235
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENTOLAMINE MESYLATE phentolamine mesylate INJECTABLE;INJECTION 040235 ANDA West-Ward Pharmaceuticals Corp 0143-9564 0143-9564-01 1 VIAL in 1 BOX (0143-9564-01) > 1 mL in 1 VIAL
PHENTOLAMINE MESYLATE phentolamine mesylate INJECTABLE;INJECTION 040235 ANDA West-Ward Pharmaceuticals Corp 0143-9564 0143-9564-10 10 VIAL in 1 BOX (0143-9564-10) > 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Mar 11, 1998TE:APRLD:No

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