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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079014
Company: NORVIUM BIOSCIENCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Discontinued None 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/2011/079014s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/2022 SUPPL-9 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

11/14/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/13/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

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