Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
| 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 |
|---|---|---|---|---|---|
| 08/28/2020 | SUPPL-78 | 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, 050629Orig1s030ltr.pdf | |
| 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 | |
| 12/20/2019 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050467s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050467Orig1s076ltr.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 |
|---|---|---|---|---|---|
| 08/28/2020 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050467s078,050629s030lbl.pdf | |
| 12/20/2019 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050467s076lbl.pdf | |
| 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 |