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
BYSTOLIC از شرکت ALLERGAN
New Drug Application (NDA): 021742
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | No |
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | No |
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | No |
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 12/17/2007 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021742s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/30/2017 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021742s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021742Orig1s022ltr.pdf |
||
| 04/20/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/2012 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/2011 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021742s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021742s013ltr.pdf |
||
| 02/19/2010 | SUPPL-7 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021742s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021742s007ltr.pdf |
||
| 10/08/2008 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/30/2017 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021742s022lbl.pdf | |
| 12/14/2011 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021742s013lbl.pdf | |
| 02/19/2010 | SUPPL-7 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021742s007lbl.pdf |
BYSTOLIC
TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021742 | ALLERGAN |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 203825 | HETERO LABS LTD III |
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021742 | ALLERGAN |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 203825 | HETERO LABS LTD III |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021742 | ALLERGAN |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203825 | HETERO LABS LTD III |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021742 | ALLERGAN |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203825 | HETERO LABS LTD III |
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