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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020544
Company: POPULATION COUNCIL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JADELLE LEVONORGESTREL 75MG/IMPLANT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** IMPLANT;IMPLANTATION Discontinued None Yes No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
11/01/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2016 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020544s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020544Orig1s010ltr.pdf
11/22/2002 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20544se2-003_jadelle_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20544se2-003ltr.pdf
01/05/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
11/05/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/20/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020544s010lbl.pdf
11/22/2002 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20544se2-003_jadelle_lbl.pdf
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