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
CEFAZOLIN SODIUM از شرکت FACTA FARMA
Abbreviated New Drug Application (ANDA): 063209
Company: FACTA FARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 20GM BASE/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 |
---|---|---|---|---|---|---|---|
12/27/1991 | 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 |
---|---|---|---|---|---|
05/29/2016 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
01/19/2012 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
01/06/2012 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
09/26/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
01/22/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
01/27/2006 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
07/27/2004 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
01/31/2001 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/30/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/25/2001 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/30/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
04/30/1999 | SUPPL-9 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
06/10/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/13/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/22/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/29/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/22/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/19/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/12/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/16/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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