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 PERRIGO UK FINCO
Abbreviated New Drug Application (ANDA): 205033
Company: PERRIGO UK FINCO
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 |
---|---|---|---|---|---|---|---|
01/23/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
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 | PERRIGO UK FINCO |
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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