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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040235
Company: HIKMA

Products on ANDA 040235

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040235

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/11/1998	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40235ap.pdf

Therapeutic Equivalents for ANDA 040235

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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