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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050778
Company: PFIZER INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELLENCE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
ELLENCE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription AP Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/26/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050778s024s025lbl.pdf
07/26/2019 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050778s024s025lbl.pdf
12/15/2014 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050778s021lbl.pdf
12/15/2014 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050778s021lbl.pdf
02/19/2013 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050778s019lbl.pdf
09/14/2011 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf
09/14/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf
09/14/2011 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf
03/02/2005 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/50778s008lbl.pdf
09/15/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50778lbl.pdf
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