Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021040
Company: TEVA WOMENS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREFEST ESTRADIOL; NORGESTIMATE 1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
10/22/1999 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21040LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21040LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021040_s000_OrthoPrefestTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2017 SUPPL-13 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021040s013lbl.pdf
07/13/2004 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21040s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21040s012ltr.pdf
11/13/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/23/2003 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr010ltr.pdf
12/19/2003 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf
10/30/2001 SUPPL-8 Labeling

Label is not available on this site.

12/19/2003 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf
01/18/2001 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/19/2003 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf
11/06/2000 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/19/2003 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf
12/19/2003 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21040slr001,002,005,007,009ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/01/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021040s013lbl.pdf
07/13/2004 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21040s012lbl.pdf
12/19/2003 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
12/19/2003 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
12/19/2003 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
12/19/2003 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
12/19/2003 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021040s009lbl.pdf
10/22/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21040LBL.PDF

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