ALFUZOSIN HYDROCHLORIDE از شرکت UNICHEM

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 UNICHEM

Abbreviated New Drug Application (ANDA): 203192

Company: UNICHEM

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
01/28/2016 ORIG-1 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203192Orig1s000ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/04/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/07/2018 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

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
حتما بخوانید : BUTRANS از شرکت PURDUE PHARMA LP
بخوانید  ALFUZOSIN HYDROCHLORIDE از شرکت APOTEX INC
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