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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021045
Company: FDN CONSUMER

Other Important Information from FDA

Products on NDA 021045

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PLAN B	LEVONORGESTREL	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PLAN B	LEVONORGESTREL	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021045

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/1999	ORIG-1	Approval	Type 3 - New Dosage Form and Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-045_Plan%20B_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-045_PlanB.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2024	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021045Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021045Orig1s018ltr.pdf
04/24/2018	SUPPL-17	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021045Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021045Orig1s017ltr.pdf
09/28/2017	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021045s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021045Orig1s016ltr.pdf
07/10/2009	SUPPL-15	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021045s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021045s015ltr.pdf
08/24/2006	SUPPL-11	Efficacy-Rx To OTC Switch	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021045s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021045s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021045s11_planb.cfm
06/21/2002	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/13/2002	SUPPL-7	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/28/2001	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/13/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/24/2000	SUPPL-4	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/30/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/12/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/28/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 021045

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2024	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021045Orig1s018lbl.pdf
03/21/2024	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021045Orig1s018lbl.pdf
04/24/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021045Orig1s017lbl.pdf
04/24/2018	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021045Orig1s017lbl.pdf
09/28/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021045s016lbl.pdf
07/10/2009	SUPPL-15	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021045s015lbl.pdf
08/24/2006	SUPPL-11	Efficacy-Rx To OTC Switch	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021045s011lbl.pdf
07/28/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21045lbl.pdf

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