Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/15/1999 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50778lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50778ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-778_Ellence.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050778s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050778Orig1s024, 050778Orig1s025ltr.pdf
07/26/2019 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050778s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050778Orig1s024, 050778Orig1s025ltr.pdf
12/15/2014 SUPPL-21 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050778s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050778Orig1s021ltr.pdf
02/19/2013 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050778s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050778Orig1s019ltr.pdf
09/14/2011 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf
09/14/2011 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf
09/14/2011 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050778s015s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050778s015,s017,s018ltr.pdf
03/02/2005 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/50778s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50778s008ltr.pdf
04/03/2003 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50778slr004ltr.pdf
04/03/2003 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50778slr004ltr.pdf
07/20/2000 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

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

ELLENCE

INJECTABLE;INJECTION; 200MG/100ML (2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELLENCE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription Yes AP 050778 PFIZER INC
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065445 ACTAVIS TOTOWA
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065361 CIPLA LTD
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065408 FRESENIUS KABI USA
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065411 FRESENIUS KABI USA
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 090075 HISUN PHARM HANGZHOU
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065331 IMPAX LABS INC
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 091599 MYLAN LABS LTD
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065289 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 50MG/25ML (2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELLENCE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription Yes AP 050778 PFIZER INC
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065445 ACTAVIS TOTOWA
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 090163 AKORN INC
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065361 CIPLA LTD
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065408 FRESENIUS KABI USA
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065411 FRESENIUS KABI USA
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 090075 HISUN PHARM HANGZHOU
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065331 IMPAX LABS INC
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 091599 MYLAN LABS LTD
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 065289 WEST-WARD PHARMS INT

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