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
CILOXAN از شرکت NOVARTIS
New Drug Application (NDA): 019992
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CILOXAN | CIPROFLOXACIN HYDROCHLORIDE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription |
AT |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/31/1990 | 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 |
|---|---|---|---|---|---|
| 03/21/2017 | SUPPL-26 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019992s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019992Orig1s026ltr.pdf |
||
| 02/07/2006 | SUPPL-20 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019992s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019992s020ltr.pdf |
||
| 08/20/2004 | SUPPL-19 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19992s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19992s019ltr.pdf |
||
| 03/13/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/2001 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1998 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1999 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/15/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1994 | SUPPL-4 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 01/22/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1993 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/12/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/21/2017 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019992s026lbl.pdf | |
| 03/21/2017 | SUPPL-26 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019992s026lbl.pdf | |
| 02/07/2006 | SUPPL-20 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019992s020lbl.pdf | |
| 08/20/2004 | SUPPL-19 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19992s019lbl.pdf |
CILOXAN
SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CILOXAN | CIPROFLOXACIN HYDROCHLORIDE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 019992 | NOVARTIS |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 076555 | AKORN |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 204613 | ALTAIRE PHARMS INC |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 077568 | FDC LTD |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 077689 | RISING |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 076754 | TELIGENT |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 0.3% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 076673 | WATSON LABS INC |
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