FDA.reportPublic FDA data

Application 050629

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION2MG/MLYesYes
002DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION200MG/100MLYesYes
003DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEINJECTABLE;INJECTION150MG/75MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-3030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3033Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3033Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3033Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3033Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3033Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3033Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3033Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3034Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3034Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3034Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3034Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3034Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3034Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-3034Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4004Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4004Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4004Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4004Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4004Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4004Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4015Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4015Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4015Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4015Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4015Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4015Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4026Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4026Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4026Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4026Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4026Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4026Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4030Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4031Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4032Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0069-4033Doxorubicin HydrochlorideDoxorubicin HydrochloridePfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78470SUPPL 2024-05-15
78469SUPPL 2024-05-15
65072SUPPL2020-10-29
64453SUPPL2020-08-31
61441SUPPL2019-12-26
61393SUPPL2019-12-23
59677SUPPL2019-08-12
59661SUPPL2019-08-12
7906SUPPL2013-11-06
17954SUPPL2013-11-01
7905SUPPL2011-09-29
17953SUPPL2011-09-26
7904SUPPL2010-08-09
17952SUPPL2010-07-30
30189SUPPL2003-05-30
7903SUPPL2003-05-30
17951SUPPL2003-05-29
17950SUPPL2003-05-13
39053SUPPL2002-09-25
17949SUPPL2002-09-25
7902SUPPL2002-09-25
7901SUPPL2002-09-25