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
ALVESCO از شرکت COVIS
New Drug Application (NDA): 021658
Company: COVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALVESCO | CICLESONIDE | 0.08MG/INH | AEROSOL, METERED;INHALATION | Prescription |
None |
Yes | Yes |
| ALVESCO | CICLESONIDE | 0.16MG/INH | AEROSOL, METERED;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 01/10/2008 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/22/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/2012 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021658Orig1s006ltr.pdf |
||
| 11/19/2012 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021658Orig1s005ltr.pdf |
||
| 12/22/2008 | SUPPL-2 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021658s002ltr.pdf |
||
| 10/10/2008 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 12/17/2012 | SUPPL-6 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s006lbl.pdf | |
| 11/19/2012 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s005lbl.pdf | |
| 12/22/2008 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658s002lbl.pdf | |
| 01/10/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021658lbl.pdf |
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