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Drugs@FDA: FDA-Approved Drugs

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

Summary Review

Products on NDA 021998

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021998

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2009	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021998s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021998_planb_onestep_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021998s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/04/2019	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021998Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021998Orig1s006ltr.pdf
12/23/2022	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021998Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021998Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021998Orig1s005SumR.pdf
08/10/2017	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021998Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021998Orig1s004ltr.pdf
06/20/2013	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021998Orig1s003ltr.pdf
04/30/2013	SUPPL-2	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021998Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021998Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021998Orig1s002.pdf

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

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

PLAN B ONE-STEP

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

TABLET;ORAL; 1.5MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ATHENTIA NEXT	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	206867	AUROBINDO PHARMA
FALLBACK SOLO	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	201446	LUPIN LTD
HER STYLE	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	207976	NOVAST LABS
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	207044	GLENMARK PHARMS LTD
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	204044	LABORATOIRE HRA
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	202739	MYLAN LABS LTD
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	202380	NAARI PTE LTD
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	207660	NAARI PTE LTD
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	202508	NOVEL LABS INC
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	202334	PERRIGO R AND D
LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	205329	XIROMED
OPCICON ONE-STEP	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	No	202635	SUN PHARM
PLAN B ONE-STEP	LEVONORGESTREL	1.5MG	TABLET;ORAL	Over-the-counter	Yes	021998	FDN CONSUMER

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