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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079060
Company: AUROBINDO PHARMA LTD

Products on ANDA 079060

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 079060

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2022	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/07/2018	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/14/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/14/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079060

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	079057	SUN PHARM
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	CONCORDIA

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