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
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER از شرکت BAYER PHARMS
New Drug Application (NDA): 019858
Company: BAYER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CIPROFLOXACIN | 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 |
|---|---|---|---|---|---|---|---|
| 12/26/1990 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 04/17/2002 | SUPPL-22 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19847s26ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019858_S022_CIPRO.pdf |
||
| 08/30/2000 | SUPPL-21 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm |
||
| 06/28/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/24/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/24/1998 | SUPPL-18 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/24/1998 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/24/1998 | SUPPL-16 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/07/1997 | SUPPL-15 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/09/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/09/1996 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/03/1998 | SUPPL-12 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 09/26/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019858_S011_CIPRO.pdf |
|
| 10/10/1996 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/21/1996 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/25/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/23/1992 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1992 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1991 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/24/1991 | 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 |
|---|---|---|---|---|---|
| 04/17/2002 | SUPPL-22 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf | |
| 08/30/2000 | SUPPL-21 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf |
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