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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090284
Company: INVAGEN PHARMS

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/17/2012 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
01/13/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
01/13/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

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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