Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079057
Company: SUN PHARMA GLOBAL
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
07/18/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079057s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/01/2015 SUPPL-9 Labeling-Package Insert, Labeling-Patient 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 079014 MYLAN
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079057 SUN PHARMA GLOBAL
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079056 TEVA PHARMS
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079054 TORRENT PHARMS
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203192 UNICHEM LABS LTD
UROXATRAL ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021287 CONCORDIA PHARMS INC

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