Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018668
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORDETTE-21 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET;ORAL-21 Discontinued None No 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
05/10/1982 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
08/09/2017 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018668s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018668Orig1s040ltr.pdf
03/06/2002 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/11/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/11/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/03/2000 SUPPL-30 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-29 Manufacturing (CMC)

Label is not available on this site.

10/11/1995 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/29/1994 SUPPL-26 Labeling

Label is not available on this site.

01/28/1994 SUPPL-25 Labeling

Label is not available on this site.

06/10/1992 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/20/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/19/1989 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/09/1988 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1988 SUPPL-19 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/08/1990 SUPPL-18 Labeling

Label is not available on this site.

04/07/1987 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1986 SUPPL-15 Labeling

Label is not available on this site.

04/18/1986 SUPPL-14 Labeling

Label is not available on this site.

09/18/1986 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1985 SUPPL-12 Labeling

Label is not available on this site.

02/19/1986 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1985 SUPPL-10 Labeling

Label is not available on this site.

07/29/1985 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1985 SUPPL-8 Labeling

Label is not available on this site.

06/25/1984 SUPPL-7 Labeling

Label is not available on this site.

03/12/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/25/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1984 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/30/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1983 SUPPL-2 Labeling

Label is not available on this site.

07/06/1982 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
08/09/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018668s040lbl.pdf

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