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
BEPREVE از شرکت BAUSCH AND LOMB INC
New Drug Application (NDA): 022288
Company: BAUSCH AND LOMB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BEPREVE | BEPOTASTINE BESILATE | 1.5% | 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 |
|---|---|---|---|---|---|---|---|
| 09/08/2009 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022288lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/09/2018 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022288s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022288Orig1s008ltr.pdf |
||
| 02/05/2016 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/2012 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022288s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022288s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/09/2018 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022288s008lbl.pdf | |
| 06/28/2012 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022288s003lbl.pdf | |
| 09/08/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022288lbl.pdf |
BEPREVE
SOLUTION/DROPS;OPHTHALMIC; 1.5%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BEPOTASTINE BESILATE | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 206066 | APOTEX |
| BEPOTASTINE BESILATE | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 206220 | MYLAN |
| BEPREVE | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 022288 | BAUSCH AND LOMB INC |
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