Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050629
Company: PFIZER
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 | Discontinued | 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 |
|---|---|---|---|---|---|
| 05/09/2024 | SUPPL-33 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050629Orig1s033Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050629Orig1s033Correctedltr.pdf | |
| 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-Package Insert, Labeling-Patient 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 |
|---|---|---|---|---|---|
| 05/09/2024 | SUPPL-33 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050629Orig1s033Correctedlbl.pdf | |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050629s022lbl.pdf | |
| 10/31/2013 | SUPPL-22 | Labeling-Patient 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 |
| 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 |