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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209148
Company: TARO
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
10/17/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209148Orig1s000Ltr.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 ALEOR DERMACEUTICALS
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
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