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
CEPTAZ از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 050646
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEPTAZ | CEFTAZIDIME | 500MG/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CEPTAZ | CEFTAZIDIME | 1GM/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CEPTAZ | CEFTAZIDIME | 2GM/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CEPTAZ | CEFTAZIDIME | 10GM/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 |
|---|---|---|---|---|---|---|---|
| 09/27/1990 | ORIG-1 | Approval |
Type 2 – New Active Ingredient |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/22/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/2002 | SUPPL-14 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050646s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf |
||
| 11/25/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/20/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/20/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/26/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/20/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/11/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/20/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/07/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/09/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1992 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1992 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/29/2002 | SUPPL-14 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050646s014lbl.pdf |
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