Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021045
Company: FDN CONSUMER
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PLAN B LEVONORGESTREL 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
PLAN B LEVONORGESTREL 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
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
04/24/2018 SUPPL-17 Labeling-Container/Carton Labels, Labeling-Package Insert 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/24/2018 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021045Orig1s017lbl.pdf
04/24/2018 SUPPL-17 Labeling-Package Insert 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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