Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211882
Company: BAUSCH

Products on NDA 211882

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211882

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/2019	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211882s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211882Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211882Orig1s000TOC.html

Labels for NDA 211882

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211882s000lbl.pdf

Therapeutic Equivalents for NDA 211882

ARAZLO

LOTION;TOPICAL; 0.045%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ARAZLO	TAZAROTENE	0.045%	LOTION;TOPICAL	Prescription	Yes	AB	211882	BAUSCH