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
BESIVANCE از شرکت BAUSCH AND LOMB
New Drug Application (NDA): 022308
Company: BAUSCH AND LOMB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BESIVANCE | BESIFLOXACIN HYDROCHLORIDE | EQ 0.6% BASE | SUSPENSION/DROPS;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 |
|---|---|---|---|---|---|---|---|
| 05/28/2009 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022308lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/03/2018 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022308s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022308s013ltr.pdf |
||
| 11/10/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/2012 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022308s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022308Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/03/2018 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022308s013lbl.pdf | |
| 09/18/2012 | SUPPL-3 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022308s003lbl.pdf | |
| 05/28/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022308lbl.pdf |
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