Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063165
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADRIAMYCIN PFS | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ADRIAMYCIN PFS | DOXORUBICIN HYDROCHLORIDE | 200MG/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/1991 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/05/2011 | SUPPL-12 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/05/2011 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2002 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/12/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1993 | SUPPL-6 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063165s006_adriamycin_toc.cfm |
| 07/09/1993 | SUPPL-5 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063165s005_adriamycin_toc.cfm |
| 06/01/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1993 | SUPPL-3 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063165s003_adriamycin_toc.cfm |
| 06/02/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/02/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |