Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075609
Company: NESHER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 1MG BASE TABLET;ORAL Discontinued None No No
DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 2MG BASE TABLET;ORAL Discontinued None No No
DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 4MG BASE TABLET;ORAL Discontinued None No No
DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 8MG BASE TABLET;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
10/18/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75609_Doxazosin%20Mesylate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75609ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075609_doxazosin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/10/2002 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/18/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75609_Doxazosin%20Mesylate_Prntlbl.pdf

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