Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206164
Company: TOLMAR

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 203790 ACTAVIS MID ATLANTIC
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 205033 PERRIGO 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English