Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018782
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORDETTE-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL-28 Discontinued None Yes No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
07/21/1982 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
08/09/2017 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018782s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018782Orig1s038ltr.pdf
06/03/2013 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018782s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018782Orig1s036ltr.pdf
03/06/2002 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/11/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/11/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/03/2000 SUPPL-23 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18-782S023.pdf
05/17/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/11/1995 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/29/1994 SUPPL-19 Labeling

Label is not available on this site.

01/28/1994 SUPPL-18 Labeling

Label is not available on this site.

06/10/1992 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/20/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/19/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/27/1988 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/08/1990 SUPPL-12 Labeling

Label is not available on this site.

07/15/1986 SUPPL-10 Labeling

Label is not available on this site.

12/27/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1985 SUPPL-8 Labeling

Label is not available on this site.

02/19/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1985 SUPPL-6 Labeling

Label is not available on this site.

07/29/1985 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/25/1984 SUPPL-3 Labeling

Label is not available on this site.

03/12/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/03/1982 SUPPL-1 Labeling

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-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018782s038lbl.pdf
06/03/2013 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018782s036lbl.pdf

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