Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206164
Company: ENCUBE
Company: ENCUBE
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 |
---|---|---|---|---|---|---|---|
05/23/2018 | 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 | 206164 | ENCUBE |
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 |
EPIDUO | ADAPALENE; BENZOYL PEROXIDE | 0.1%;2.5% | GEL;TOPICAL | Prescription | Yes | AB | 022320 | GALDERMA LABS LP |