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
ACANYA از شرکت BAUSCH
New Drug Application (NDA): 050819
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACANYA | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription |
AB |
Yes | Yes |
| ONEXTON | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 3.75%;EQ 1.2% BASE | GEL;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 |
|---|---|---|---|---|---|---|---|
| 10/23/2008 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050819lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/21/2020 | SUPPL-24 | Labeling-Patient Package Insert, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050819Orig1s023, s024ltr.pdf |
||
| 02/21/2020 | SUPPL-23 | Labeling-Patient Package Insert, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050819Orig1s023, s024ltr.pdf |
||
| 03/25/2016 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/2015 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/2014 | SUPPL-12 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/050819Orig1s012.pdf |
||
| 03/18/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2014 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s010ltr.pdf |
||
| 12/18/2012 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/2010 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050819s003ltr.pdf |
||
| 06/23/2010 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050819s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/21/2020 | SUPPL-24 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf | |
| 02/21/2020 | SUPPL-24 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf | |
| 02/21/2020 | SUPPL-23 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf | |
| 02/21/2020 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf | |
| 11/24/2014 | SUPPL-12 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s012lbl.pdf | |
| 02/28/2014 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s010lbl.pdf | |
| 10/18/2010 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s003lbl.pdf | |
| 06/23/2010 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s002lbl.pdf | |
| 10/23/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050819lbl.pdf |
ACANYA
GEL;TOPICAL; 2.5%;EQ 1.2% BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACANYA | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | Yes | AB | 050819 | BAUSCH |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | No | AB | 205128 | ACTAVIS LABS UT INC |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | No | AB | 205397 | PADAGIS ISRAEL |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | No | AB | 206575 | TARO |
ONEXTON
There are no Therapeutic Equivalents.
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