Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207686
Company: PRECISION DOSE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENTOLAMINE MESYLATE PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/14/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

PHENTOLAMINE MESYLATE

INJECTABLE;INJECTION; 5MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENTOLAMINE MESYLATE PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE;INJECTION Prescription No AP 207686 PRECISION DOSE INC
PHENTOLAMINE MESYLATE PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE;INJECTION Prescription No AP 040235 WEST-WARD PHARMS INT

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