Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020713
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRCETTE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-28 Discontinued None Yes No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
04/22/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20713.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020713s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020713Orig1s011ltr.pdf
07/18/2012 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020713s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020713Orig1s010ltr.pdf
03/08/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2000 SUPPL-7 Labeling

Label is not available on this site.

11/27/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/30/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/15/2000 SUPPL-4 Labeling

Label is not available on this site.

03/16/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/19/1998 SUPPL-2 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
08/09/2017 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020713s011lbl.pdf
07/18/2012 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020713s010lbl.pdf

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