Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074539
Company: PHARMACHEMIE
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 |