Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021998
Company: FDN CONSUMER

• Summary Review

Products on NDA 21998

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PLAN B ONE-STEP	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	None	Yes	Yes

Labels for NDA 021998

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2022	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021998Orig1s005lbl.pdf
01/04/2019	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021998Orig1s006lbl.pdf
08/10/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021998Orig1s004lbl.pdf
06/20/2013	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s003lbl.pdf
04/30/2013	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s002lbl.pdf
07/10/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf