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
BROMDAY از شرکت BAUSCH AND LOMB INC
New Drug Application (NDA): 021664
Company: BAUSCH AND LOMB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BROMDAY | BROMFENAC SODIUM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued |
None |
Yes | No |
| XIBROM | BROMFENAC SODIUM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS;OPHTHALMIC | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 03/24/2005 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021664lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/11/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/2014 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021664Orig1s014,s019ltr.pdf |
||
| 01/27/2014 | SUPPL-14 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021664Orig1s014,s019ltr.pdf |
||
| 10/16/2010 | SUPPL-13 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021664s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021664s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021664Orig1s013.pdf |
||
| 06/02/2009 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021664s010ltr.pdf |
||
| 01/27/2006 | SUPPL-1 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021664s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021664s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/27/2014 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf | |
| 01/27/2014 | SUPPL-14 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021664s014s019lbl.pdf | |
| 10/16/2010 | SUPPL-13 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021664s013lbl.pdf | |
| 06/02/2009 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021664s010lbl.pdf | |
| 01/27/2006 | SUPPL-1 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021664s001lbl.pdf | |
| 03/24/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021664lbl.pdf |
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