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 |
| 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 |