Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209354
Company: BAUSCH

Products on NDA 209354

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUOBRII	HALOBETASOL PROPIONATE; TAZAROTENE	0.01%;0.045%	LOTION;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209354

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2019	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209354s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209354Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209354Orig1s000TOC.html

Labels for NDA 209354

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209354s000lbl.pdf

Therapeutic Equivalents for NDA 209354

DUOBRII

LOTION;TOPICAL; 0.01%;0.045%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DUOBRII	HALOBETASOL PROPIONATE; TAZAROTENE	0.01%;0.045%	LOTION;TOPICAL	Prescription	Yes	AB	209354	BAUSCH
HALOBETASOL PROPIONATE AND TAZAROTENE	HALOBETASOL PROPIONATE; TAZAROTENE	0.01%;0.045%	LOTION;TOPICAL	Prescription	No	AB	217190	SUN PHARMA CANADA