ALFUZOSIN HYDROCHLORIDE از شرکت AUROBINDO PHARMA LTD

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ALFUZOSIN HYDROCHLORIDE از شرکت AUROBINDO PHARMA LTD

Abbreviated New Drug Application (ANDA): 079060

Company: AUROBINDO PHARMA LTD

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE;ORALPrescription

AB

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
08/30/2012ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
12/07/2018SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/14/2015SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/14/2015SUPPL-3 Labeling-Package Insert

Label is not available on this site.

ALFUZOSIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 10MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB079013APOTEX INC
ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB079060AUROBINDO PHARMA LTD
ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB090284INVAGEN PHARMS
ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB079057SUN PHARM
ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB203192UNICHEM
UROXATRALALFUZOSIN HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE;ORALPrescriptionYesAB021287CONCORDIA
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