Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074539
Company: PHARMACHEMIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 10MG 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
03/31/2003 ORIG-1 Approval Letter (PDF)
Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74539ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74539ta3.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074539.PDF

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