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
ALTABAX از شرکت ALMIRALL
New Drug Application (NDA): 022055
Company: ALMIRALL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALTABAX | RETAPAMULIN | 1% | OINTMENT;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/12/2007 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022055lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/10/2019 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022055s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022055Orig1s007ltr.pdf |
||
| 06/17/2014 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2010 | SUPPL-4 | Labeling, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022055s004ltr.pdf |
||
| 08/01/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/2012 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022055s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022055Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/10/2019 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022055s007lbl.pdf | |
| 12/21/2012 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022055s002lbl.pdf | |
| 09/28/2010 | SUPPL-4 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf | |
| 09/28/2010 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf | |
| 04/12/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022055lbl.pdf |
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