Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022070
Company: DOW PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATRALIN TRETINOIN 0.05% 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
07/26/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022070s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022070_atralin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/29/2014 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022070s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022070Orig1s003ltr.pdf
03/06/2008 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/29/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022070s003lbl.pdf
07/26/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022070lbl.pdf

ATRALIN

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATRALIN TRETINOIN 0.05% GEL;TOPICAL Prescription Yes AB 022070 DOW PHARM
TRETINOIN TRETINOIN 0.05% GEL;TOPICAL Prescription No AB 207955 MYLAN PHARMS INC

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