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
BENZACLIN از شرکت BAUSCH
New Drug Application (NDA): 050756
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENZACLIN | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription |
AB |
Yes | Yes |
| BENZACLIN | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Discontinued |
None |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/21/2000 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/05/2014 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/2011 | SUPPL-40 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050756s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050756s040ltr.pdf |
||
| 06/17/2010 | SUPPL-37 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050756s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050756s037ltr.pdf |
||
| 06/14/2010 | SUPPL-35 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/12/2009 | SUPPL-34 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050756s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050756s034ltr.pdf |
||
| 04/20/2007 | SUPPL-27 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050756s027ltr.pdf |
||
| 05/23/2007 | SUPPL-26 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050756s026ltr.pdf |
||
| 04/28/2005 | SUPPL-16 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050756s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050756s016ltr.pdf |
||
| 08/28/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50756s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50756scp007ltr.pdf |
||
| 03/26/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/2001 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/2001 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/02/2011 | SUPPL-40 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050756s040lbl.pdf |
| 06/17/2010 | SUPPL-37 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050756s037lbl.pdf | |
| 06/12/2009 | SUPPL-34 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050756s034lbl.pdf | |
| 05/23/2007 | SUPPL-26 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s026lbl.pdf | |
| 04/20/2007 | SUPPL-27 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s027lbl.pdf | |
| 04/28/2005 | SUPPL-16 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050756s016lbl.pdf | |
| 08/09/2002 | SUPPL-7 |
Manufacturing (CMC)-Packaging |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50756s7lbl.pdf | |
| 12/21/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin_prntlbl.pdf |
BENZACLIN
GEL;TOPICAL; 5%;EQ 1% BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENZACLIN | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | Yes | AB | 050756 | BAUSCH |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 209252 | GLENMARK PHARMS |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 065443 | MYLAN PHARMS INC |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 202440 | PADAGIS ISRAEL |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 208776 | TARO |
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