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 ALMIRALL
New Drug Application (NDA): 207154
Company: ALMIRALL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACZONE | DAPSONE | 7.5% | 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 |
|---|---|---|---|---|---|---|---|
| 02/24/2016 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207154s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/10/2019 | SUPPL-4 | Efficacy-New Patient Population, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207154s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207154Orig1s004ltr.pdf |
||
| 05/18/2018 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207154s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207154Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/10/2019 | SUPPL-4 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207154s004lbl.pdf | |
| 09/10/2019 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207154s004lbl.pdf | |
| 05/18/2018 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207154s003lbl.pdf | |
| 02/24/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207154s000lbl.pdf |
ACZONE
GEL;TOPICAL; 7.5%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACZONE | DAPSONE | 7.5% | GEL;TOPICAL | Prescription | Yes | AB | 207154 | ALMIRALL |
| DAPSONE | DAPSONE | 7.5% | GEL;TOPICAL | Prescription | No | AB | 210191 | TARO PHARMS |
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