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
CEFADROXIL از شرکت IVAX SUB TEVA PHARMS
Abbreviated New Drug Application (ANDA): 062766
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/03/1987 | 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 |
|---|---|---|---|---|---|
| 08/20/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/21/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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