Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050661
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IDAMYCIN IDARUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE;INJECTION Discontinued None No No
IDAMYCIN IDARUBICIN HYDROCHLORIDE 5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
IDAMYCIN IDARUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION 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
09/27/1990 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/2019 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050661s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050661Orig1s015ltr.pdf
12/04/2014 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050661s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050661Orig1s014ltr.pdf
04/02/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/21/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/11/2002 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50661slr008ltr.pdf
09/30/2002 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50661slr007ltr.pdf
04/22/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/11/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1995 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/07/1991 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/02/2019 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050661s015lbl.pdf
12/04/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050661s014lbl.pdf

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