Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021753
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFFERIN ADAPALENE 0.3% GEL;TOPICAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/19/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021753lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021753s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021753TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2014 SUPPL-7 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021753Orig1s007ltr.pdf
02/27/2012 SUPPL-4 Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021753s004lbl.pdf
09/01/2010 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021753s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021753s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/27/2012 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021753s004lbl.pdf
09/01/2010 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021753s002lbl.pdf
06/19/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021753lbl.pdf

DIFFERIN

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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