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Drugs@FDA: FDA-Approved Drugs

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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	Labeling-Package Insert, Efficacy-New Patient Population	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	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207154s004lbl.pdf
09/10/2019	SUPPL-4	Efficacy-New Patient Population	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
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	213636	TRUPHARMA
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	214019	ZYDUS LIFESCIENCES

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