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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022070
Company: DOW PHARM

Products on NDA 022070

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATRALIN	TRETINOIN	0.05%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022070

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.

Labels for NDA 022070

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

Therapeutic Equivalents for NDA 022070

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

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