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
ACZONE از شرکت ALLERGAN
New Drug Application (NDA): 021794
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACZONE | DAPSONE | 5% | GEL;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/07/2005 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/18/2018 | SUPPL-16 | Labeling-Patient Package Insert, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021794Orig1s016ltr.pdf |
||
| 09/03/2015 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2015 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021794Orig1s013ltr.pdf |
||
| 11/08/2013 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/03/2013 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/2013 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/2009 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf |
||
| 03/14/2008 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021794s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/18/2018 | SUPPL-16 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf | |
| 05/18/2018 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf | |
| 07/09/2015 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf | |
| 03/26/2009 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf | |
| 03/26/2009 | SUPPL-6 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf | |
| 03/14/2008 | SUPPL-5 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf | |
| 07/07/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf |
ACZONE
GEL;TOPICAL; 5%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACZONE | DAPSONE | 5% | GEL;TOPICAL | Prescription | Yes | AB | 021794 | ALLERGAN |
| DAPSONE | DAPSONE | 5% | GEL;TOPICAL | Prescription | No | AB | 209506 | TARO |
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