An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Package Insert, Labeling-Patient 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-Container/Carton Labels, Labeling-Package Insert	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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf
05/18/2018	SUPPL-16	Labeling-Patient 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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf
03/26/2009	SUPPL-6	Labeling-Package Insert	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	213907	BELOTECA
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

Top