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 PERRIGO ISRAEL
Abbreviated New Drug Application (ANDA): 205397
Company: PERRIGO ISRAEL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% 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 |
|---|---|---|---|---|---|---|---|
| 09/09/2019 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205397Orig1s000TAltr.pdf |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
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 | PERRIGO ISRAEL |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL;TOPICAL | Prescription | No | AB | 206575 | TARO |
منبع : www.accessdata.fda.gov
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