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): 207154
Company: ALMIRALL

Products on NDA 207154

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACZONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207154

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207154s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207154Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207154Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2019	SUPPL-4	Efficacy-New Patient Population, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207154s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207154Orig1s004ltr.pdf
05/18/2018	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207154s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207154Orig1s003ltr.pdf

Labels for NDA 207154

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2019	SUPPL-4	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207154s004lbl.pdf
09/10/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207154s004lbl.pdf
05/18/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207154s003lbl.pdf
02/24/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207154s000lbl.pdf

Therapeutic Equivalents for NDA 207154

ACZONE

GEL;TOPICAL; 7.5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACZONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	Yes	AB	207154	ALMIRALL
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	215718	ALEMBIC
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	212701	AMNEAL
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	213847	MYLAN
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	210191	TARO
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	214722	TORRENT

Top