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
ADAPALENE AND BENZOYL PEROXIDE از شرکت TARO
Abbreviated New Drug Application (ANDA): 206959
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | 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 |
|---|---|---|---|---|---|---|---|
| 01/24/2018 | ORIG-2 | Approval |
Labeling |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206959Orig1s000ltr.pdf |
| 01/24/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206959Orig1s000TAltr.pdf |
ADAPALENE AND BENZOYL PEROXIDE
GEL;TOPICAL; 0.1%;2.5%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | No | AB | 203790 | ACTAVIS MID ATLANTIC |
| ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | No | AB | 208108 | GLENMARK PHARMS LTD |
| ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | No | AB | 205033 | PADAGIS ISRAEL |
| ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | No | AB | 206959 | TARO |
| ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | No | AB | 206164 | TOLMAR |
| EPIDUO | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | Yes | AB | 022320 | GALDERMA LABS LP |
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