Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215602
Company: AZURITY

Products on NDA 215602

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLEQSUVY	BACLOFEN	25MG/5ML	SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215602

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/04/2022	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215602s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215602Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215602Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215602s003lbl.pdf

Labels for NDA 215602

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215602s003lbl.pdf
02/04/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215602s000lbl.pdf

Therapeutic Equivalents for NDA 215602

FLEQSUVY

SUSPENSION;ORAL; 25MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACLOFEN	BACLOFEN	25MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	217252	ANI PHARMS
FLEQSUVY	BACLOFEN	25MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	215602	AZURITY