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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079013
Company: APOTEX INC

Products on ANDA 079013

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079013

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/2011	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079013s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2022	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
12/07/2018	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
01/15/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/15/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079013

ALFUZOSIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	079013	APOTEX INC
ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	079060	AUROBINDO PHARMA LTD
ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090284	INVAGEN PHARMS
ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203192	UNICHEM
UROXATRAL	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021287	ADVANZ PHARMA

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