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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021952
Company: BAYER HEALTHCARE LLC

Summary Review

Products on NDA 021952

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLARITIN	LORATADINE	10MG	CAPSULE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021952

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021952s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021952_claritin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021952s000_SUMR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2023	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021952Orig1s022lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021952Orig1s022ltr.pdf
12/21/2018	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s055,021952Orig1s018Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019658Orig1s055,021952Orig1s018Ltr.pdf
07/20/2018	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s017Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s017Ltr.pdf
06/20/2018	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s016ltr.pdf
06/04/2018	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s015ltr.pdf
04/18/2018	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s014ltr.pdf
12/09/2015	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021952Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021952Orig1s012ltr.pdf
04/06/2009	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021952s003ltr.pdf

Labels for NDA 021952

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2023	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021952Orig1s022lbledt.pdf
12/21/2018	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s055,021952Orig1s018Lbl.pdf
07/20/2018	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s017Lbl.pdf
06/20/2018	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s016lbl.pdf
06/04/2018	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s015lbl.pdf
04/18/2018	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s014lbl.pdf
12/09/2015	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021952Orig1s012lbl.pdf

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

CLARITIN

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

CAPSULE;ORAL; 10MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CLARITIN	LORATADINE	10MG	CAPSULE;ORAL	Over-the-counter	Yes	021952	BAYER HEALTHCARE LLC
LORATADINE	LORATADINE	10MG	CAPSULE;ORAL	Over-the-counter	No	202538	BIONPHARMA
LORATADINE	LORATADINE	10MG	CAPSULE;ORAL	Over-the-counter	No	206214	MARKSANS PHARMA

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