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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207686
Company: PRECISION DOSE INC

Products on ANDA 207686

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207686

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.

Therapeutic Equivalents for ANDA 207686

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	040235	HIKMA
PHENTOLAMINE MESYLATE	PHENTOLAMINE MESYLATE	5MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207686	PRECISION DOSE INC

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