FDA.reportPublic FDA data

Application 050778

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELLENCEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION200MG/100ML (2MG/ML)YesYes
002ELLENCEEPIRUBICIN HYDROCHLORIDEINJECTABLE;INJECTION50MG/25ML (2MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-5091Ellenceepirubicin hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-5091Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5091Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5091Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5091Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5091Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5091Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5093Ellenceepirubicin hydrochloridePharmacia & Upjohn Company LLCNDACurrent
0009-5093Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5093Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5093Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5093Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5093Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent
0009-5093Ellenceepirubicin hydrochloridePharmacia and Upjohn Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80884SUPPL 2025-01-21
80883SUPPL 2025-01-21
66305SUPPL2021-02-22
59483SUPPL2019-10-15
59498SUPPL2019-07-30
59497SUPPL2019-07-30
59482SUPPL2019-07-29
18229SUPPL2014-12-16
8266SUPPL2014-12-16
18228SUPPL2013-02-21
8265SUPPL2013-02-21
30520SUPPL2011-09-19
30519SUPPL2011-09-19
8264SUPPL2011-09-19
39317SUPPL2011-09-16
39316SUPPL2011-09-16
39315SUPPL2011-09-16
39314SUPPL2005-03-10
8263SUPPL2005-03-10
22234ORIG2004-06-03
30518SUPPL2003-04-18
8262SUPPL2003-04-18
39313ORIG1999-09-15
30517ORIG1999-09-15