اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ADRIAMYCIN PFS از شرکت PFIZER
Abbreviated New Drug Application (ANDA): 063165
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 |
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) |
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) |
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. |
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