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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021794
Company: ABBVIE

Products on NDA 021794

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACZONE	DAPSONE	5%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021794

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021794ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021794s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/18/2018	SUPPL-16	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021794Orig1s016ltr.pdf
09/03/2015	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
07/09/2015	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021794Orig1s013ltr.pdf
11/08/2013	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
10/03/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/31/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/26/2009	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf
03/14/2008	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021794s005ltr.pdf

Labels for NDA 021794

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/18/2018	SUPPL-16	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf
05/18/2018	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf
07/09/2015	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf
03/26/2009	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf
03/26/2009	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf
03/14/2008	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf
07/07/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf

Therapeutic Equivalents for NDA 021794

ACZONE

GEL;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACZONE	DAPSONE	5%	GEL;TOPICAL	Prescription	Yes	AB	021794	ABBVIE
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	209890	AMNEAL
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	210178	COSETTE
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	212383	ENCUBE
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	209506	TARO
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	213907	TRUPHARMA

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