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
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE از شرکت MYLAN PHARMS INC
Abbreviated New Drug Application (ANDA): 065443
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 08/11/2009 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/065443Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/01/2018 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/12/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
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 |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 204087 | TOLMAR |
منبع : www.accessdata.fda.gov
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