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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021993
Company: BAYER HEALTHCARE LLC

Products on NDA 021993

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLARITIN REDITABS	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021993

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/2006	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021993s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021993s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021993_claritin_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2023	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021993Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021993Orig1s023ltr.pdf
02/28/2019	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s034,021993Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020704Orig1s034, 021993Orig1s017ltr.pdf
07/23/2018	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021993Orig1s016,020704Orig1s033ltr.pdf
11/25/2015	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021993Orig1s013,020704Orig1s028ltr.pdf
07/22/2014	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020704Orig1s027,021993Orig1s012ltr.pdf
10/21/2008	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021993s004ltr.pdf

Labels for NDA 021993

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2023	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021993Orig1s023lbl.pdf
02/28/2019	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s034,021993Orig1s017lbl.pdf
07/23/2018	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf
11/25/2015	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf
07/22/2014	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf
12/12/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021993s000lbl.pdf

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

CLARITIN REDITABS

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

TABLET, ORALLY DISINTEGRATING;ORAL; 5MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CLARITIN REDITABS	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	Yes	021993	BAYER HEALTHCARE LLC
LORATADINE	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Over-the-counter	No	212795	TENSHI

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