Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212464
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.3%;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 |
---|---|---|---|---|---|---|---|
05/31/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212464Orig1s000TAltr.pdf |
ADAPALENE AND BENZOYL PEROXIDE
GEL;TOPICAL; 0.3%;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 | 0.3%;2.5% | GEL;TOPICAL | Prescription | No | AB | 209641 | ACTAVIS LABS UT INC |
ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.3%;2.5% | GEL;TOPICAL | Prescription | No | AB | 214185 | ALEMBIC |
ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.3%;2.5% | GEL;TOPICAL | Prescription | No | AB | 212464 | PADAGIS ISRAEL |
ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.3%;2.5% | GEL;TOPICAL | Prescription | No | AB | 209148 | TARO |
ADAPALENE AND BENZOYL PEROXIDE | ADAPALENE; BENZOYL PEROXIDE | 0.3%;2.5% | GEL;TOPICAL | Prescription | No | AB | 214553 | ZYDUS PHARMS |
EPIDUO FORTE | ADAPALENE; BENZOYL PEROXIDE | 0.3%;2.5% | GEL;TOPICAL | Prescription | Yes | AB | 207917 | GALDERMA LABS |