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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050734
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IDAMYCIN PFS IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/06/2026 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050734Orig1s032lbl.pdf
11/06/2023 SUPPL-31 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050734Orig1s031lbl.pdf
04/27/2022 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050734s029lbl.pdf
02/10/2021 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050734s027lbl.pdf
08/02/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050734s025lbl.pdf
12/04/2014 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050734s022lbl.pdf
05/01/2003 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050734s005lbl.pdf
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