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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209090
Company: CHATTEM SANOFI

Products on NDA 209090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XYZAL ALLERGY 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2017	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209089Orig1s000,209090Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209089Orig1s000,209090Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209089Orig1s000_209090Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2022	SUPPL-4		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209090Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209090Orig1s004ltr.pdf
07/13/2022	SUPPL-3	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209090Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209090Orig1s003ltr.pdf
11/10/2020	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209090Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209090Orig1s002ltr.pdf

Labels for NDA 209090

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2022	SUPPL-4	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209090Orig1s004lbl.pdf
07/13/2022	SUPPL-3	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209090Orig1s003lbl.pdf
11/10/2020	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209090Orig1s002lbl.pdf
01/31/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209089Orig1s000,209090Orig1s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

XYZAL ALLERGY 24HR

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION;ORAL; 2.5MG/5ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
XYZAL ALLERGY 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION;ORAL	Over-the-counter	Yes	209090	CHATTEM SANOFI

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