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 TOLMAR
Abbreviated New Drug Application (ANDA): 203688
Company: TOLMAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | 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 |
|---|---|---|---|---|---|---|---|
| 08/25/2016 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/25/2016 | SUPPL-1 |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
GEL;TOPICAL; 5%;1.2%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | No | AB | 212433 | ENCUBE |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | No | AB | 090979 | PERRIGO ISRAEL |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | No | AB | 206218 | TARO PHARMS |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | No | AB | 203688 | TOLMAR |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | No | AB | 210794 | ZYDUS PHARMS |
| DUAC | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 5%;1.2% | GEL;TOPICAL | Prescription | Yes | AB | 050741 | STIEFEL |
منبع : www.accessdata.fda.gov
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