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 1MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/17/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/10/2021 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050734s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050734Orig1s027ltr.pdf
08/02/2019 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050734s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050734Orig1s025ltr.pdf
12/04/2014 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050734s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050734Orig1s022ltr.pdf
11/05/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2002 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/21/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/31/2000 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/01/2003 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050734s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50734slr005ltr.pdf
08/12/1999 SUPPL-4 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

IDAMYCIN PFS

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IDAMYCIN PFS IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 050734 PFIZER
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 065440 FRESENIUS KABI USA
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 065275 HIKMA
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 065288 HIKMA
IDARUBICIN HYDROCHLORIDE PFS IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 065036 TEVA PHARMS USA

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