Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090824
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADAPALENE ADAPALENE 0.1% CREAM;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
06/30/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090824s000ltr.pdf

ADAPALENE

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADAPALENE ADAPALENE 0.1% CREAM;TOPICAL Prescription No AB 090824 FOUGERA PHARMS
DIFFERIN ADAPALENE 0.1% CREAM;TOPICAL Prescription Yes AB 020748 GALDERMA LABS LP

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