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
AEROSPAN HFA از شرکت MYLAN SPECIALITY LP
New Drug Application (NDA): 021247
Company: MYLAN SPECIALITY LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AEROSPAN HFA | FLUNISOLIDE | 0.078MG/INH | AEROSOL, METERED;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/2006 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021247LBL.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/25/2018 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021247s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021247Orig1s017ltr.pdf |
||
| 11/17/2017 | SUPPL-16 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021247s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021247Orig1s016ltr.pdf |
||
| 06/23/2017 | SUPPL-15 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021247s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021247Orig1s015ltr.pdf |
||
| 04/22/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2016 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/2013 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/2013 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021247s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021247Orig1s008ltr.pdf |
||
| 11/16/2012 | SUPPL-7 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021247s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021247Orig1s007ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/25/2018 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021247s017lbl.pdf | |
| 11/17/2017 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021247s016lbl.pdf | |
| 06/23/2017 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021247s015lbl.pdf | |
| 08/28/2013 | SUPPL-8 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021247s008lbl.pdf | |
| 11/16/2012 | SUPPL-7 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021247s007lbl.pdf | |
| 01/27/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021247LBL.pdf |
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