Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204522
Company: PAR PHARM INC

Products on ANDA 204522

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204522

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204522Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 204522

PHENOXYBENZAMINE HYDROCHLORIDE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIBENZYLINE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	Yes	AB	008708	CONCORDIA
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	212568	AMNEAL
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	215600	AUROBINDO PHARMA
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	215042	NOVITIUM PHARMA
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	204522	PAR PHARM INC
PHENOXYBENZAMINE HYDROCHLORIDE	PHENOXYBENZAMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Prescription	No	AB	204551	RISING