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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050629
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 150MG/75ML INJECTABLE;INJECTION Prescription None 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
12/23/1987 ORIG-1 Approval Type 3 - New Dosage Form 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
08/28/2020 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050467s078,050629s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050467Orig1s078,%20050629Orig1s030ltr.pdf
08/09/2019 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050629s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050629Orig1s029ltr.pdf
12/20/2019 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050629s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050629Orig1s028ltr.pdf
12/05/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
10/23/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
10/10/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
10/31/2013 SUPPL-22 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050629s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050629Orig1s022ltr.pdf
09/26/2011 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050629s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050467s071,050629s019ltr.pdf
03/28/2011 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
07/30/2010 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050629s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050467s070,050629s017ltr.pdf
05/08/2003 SUPPL-16 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-14 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-13 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-12 Manufacturing (CMC)

Label is not available on this site.
01/10/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
09/25/2002 SUPPL-10 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
08/10/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
08/10/2000 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/04/1999 SUPPL-7 Labeling

Label is not available on this site.
02/13/1998 SUPPL-6 Labeling

Label is not available on this site.
09/15/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
09/05/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
05/03/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
11/29/1994 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/28/2020 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050467s078,050629s030lbl.pdf
12/20/2019 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050629s028lbl.pdf
08/09/2019 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050629s029lbl.pdf
10/31/2013 SUPPL-22 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050629s022lbl.pdf
10/31/2013 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050629s022lbl.pdf
09/26/2011 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050629s019lbl.pdf
07/30/2010 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050629s017lbl.pdf
05/08/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50629se1-014slr016,50467se1-068,slr069_doxorubicin_lbl.pdf
05/08/2003 SUPPL-14 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050467s068lbl.pdf
09/25/2002 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf
09/25/2002 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf

DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 203622 ACTAVIS INC
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 063277 FRESENIUS KABI USA
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 209825 GLAND PHARMA LTD
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 062975 HIKMA
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription Yes AP 050629 PFIZER
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 091495 SAGENT PHARMS
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 091418 SUN PHARM INDS

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription No AP 203622 ACTAVIS INC
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription No AP 064097 HIKMA
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription Yes AP 050629 PFIZER
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