Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203790
Company: ACTAVIS MID ATLANTIC
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
09/30/2015 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203790Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203790Orig1s000TAltr.pdf

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
EPIDUO ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription Yes AB 022320 GALDERMA LABS LP

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