Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050467
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE;INJECTION Discontinued None No No
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE;INJECTION Discontinued None No No
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION Discontinued None No No
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 150MG/VIAL INJECTABLE;INJECTION Discontinued None No 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
08/07/1974 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2019 SUPPL-77 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050467s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050467Orig1s077ltr.pdf
09/10/2015 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

10/10/2013 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

10/31/2013 SUPPL-73 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050467s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050467Orig1s073ltr.pdf
09/26/2011 SUPPL-71 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050467s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050467s071,050629s019ltr.pdf
07/30/2010 SUPPL-70 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050467s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050467s070,050629s017ltr.pdf
05/08/2003 SUPPL-69 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50629se1-014slr016,50467se1-068,slr069_doxorubicin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50629se1-014slr016,50467se1-068,slr069ltr.pdf
05/08/2003 SUPPL-68 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050467s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50629se1-014slr016,50467se1-068,slr069ltr.pdf
09/25/2002 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629slr010,013ltr.pdf
04/02/2002 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

01/10/2002 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

09/25/2002 SUPPL-64 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629slr010,013ltr.pdf
03/04/1999 SUPPL-63 Labeling

Label is not available on this site.

02/13/1998 SUPPL-62 Labeling

Label is not available on this site.

10/14/1997 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

05/03/1996 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1995 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/25/1988 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1987 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1987 SUPPL-55 Labeling

Label is not available on this site.

07/22/1987 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1987 SUPPL-53 Labeling

Label is not available on this site.

02/19/1987 SUPPL-52 Labeling

Label is not available on this site.

03/27/1987 SUPPL-50 Labeling

Label is not available on this site.

03/25/1987 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1987 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1986 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

05/21/1986 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1986 SUPPL-45 Labeling

Label is not available on this site.

02/11/1986 SUPPL-44 Labeling

Label is not available on this site.

06/07/1985 SUPPL-42 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/20/1985 SUPPL-41 Labeling

Label is not available on this site.

03/04/1985 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1985 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1983 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/10/1983 SUPPL-36 Labeling

Label is not available on this site.

02/24/1983 SUPPL-35 Labeling

Label is not available on this site.

03/15/1982 SUPPL-34 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/15/1982 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1981 SUPPL-32 Labeling

Label is not available on this site.

03/31/1980 SUPPL-30 Labeling

Label is not available on this site.

10/31/1979 SUPPL-29 Labeling

Label is not available on this site.

10/30/1979 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/30/1979 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/14/1979 SUPPL-26 Labeling

Label is not available on this site.

12/07/1978 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/1978 SUPPL-24 Labeling

Label is not available on this site.

07/03/1978 SUPPL-23 Labeling

Label is not available on this site.

09/13/1978 SUPPL-22 Labeling

Label is not available on this site.

01/09/1978 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/18/1977 SUPPL-20 Labeling

Label is not available on this site.

08/10/1977 SUPPL-19 Labeling

Label is not available on this site.

07/25/1977 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1977 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/25/1977 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/1977 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/22/1977 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/22/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1977 SUPPL-12 Labeling

Label is not available on this site.

12/21/1976 SUPPL-11 Labeling

Label is not available on this site.

09/14/1976 SUPPL-10 Labeling

Label is not available on this site.

03/25/1976 SUPPL-9 Labeling

Label is not available on this site.

11/25/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1975 SUPPL-7 Labeling

Label is not available on this site.

08/25/1975 SUPPL-6 Labeling

Label is not available on this site.

05/12/1975 SUPPL-5 Labeling

Label is not available on this site.

05/05/1975 SUPPL-4 Labeling

Label is not available on this site.

11/29/1994 SUPPL-2 Labeling

Label is not available on this site.

11/13/1974 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2019 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050467s077lbl.pdf
10/31/2013 SUPPL-73 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050467s073lbl.pdf
10/31/2013 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050467s073lbl.pdf
09/26/2011 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050467s071lbl.pdf
07/30/2010 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050467s070lbl.pdf
05/08/2003 SUPPL-69 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50629se1-014slr016,50467se1-068,slr069_doxorubicin_lbl.pdf
05/08/2003 SUPPL-68 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050467s068lbl.pdf
09/25/2002 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf
09/25/2002 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf

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