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): 020369
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CILOXAN | CIPROFLOXACIN HYDROCHLORIDE | EQ 0.3% BASE | OINTMENT;OPHTHALMIC | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 03/30/1998 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20369lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/17/2017 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020369s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020369Orig1s022ltr.pdf |
||
| 08/05/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/2004 | SUPPL-10 | Manufacturing (CMC)-Packaging |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20369s009,010ltr.pdf |
||
| 07/15/2004 | SUPPL-9 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20369s009,010ltr.pdf |
||
| 08/19/2003 | SUPPL-7 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20369scm006,slr007ltr.pdf |
||
| 08/19/2003 | SUPPL-6 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20369scm006,slr007ltr.pdf |
||
| 12/11/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/28/1999 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/07/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1999 | 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 |
|---|---|---|---|---|---|
| 02/17/2017 | SUPPL-22 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020369s022lbl.pdf | |
| 02/17/2017 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020369s022lbl.pdf | |
| 07/15/2004 | SUPPL-10 |
Manufacturing (CMC)-Packaging |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf | |
| 07/15/2004 | SUPPL-9 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf | |
| 08/19/2003 | SUPPL-7 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf | |
| 08/19/2003 | SUPPL-6 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf |
| 03/30/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20369lbl.pdf |
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