Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201000
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADAPALENE ADAPALENE 0.3% 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
10/27/2014 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201000Orig1s000ltr.pdf

ADAPALENE

GEL;TOPICAL; 0.3%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADAPALENE ADAPALENE 0.3% GEL;TOPICAL Prescription No AB 201000 ACTAVIS MID ATLANTIC
ADAPALENE ADAPALENE 0.3% GEL;TOPICAL Prescription No AB 208322 TARO
ADAPALENE ADAPALENE 0.3% GEL;TOPICAL Prescription No AB 200298 TOLMAR
DIFFERIN ADAPALENE 0.3% GEL;TOPICAL Prescription Yes AB 021753 GALDERMA LABS LP

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