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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017802
Company: WYETH PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LO/OVRAL-28 ETHINYL ESTRADIOL; NORGESTREL 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL-28 Discontinued None Yes No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
03/16/1976 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
04/29/2022 SUPPL-35 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017802s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017802Orig1s035ltr.pdf
05/08/2019 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017802s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017802Orig1s034, 017948Orig1s046, 018926Orig1s013, 019190Orig1s049, 019192Orig1s048ltr.pdf
03/20/2018 SUPPL-33 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017802s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017802Orig1s033ltr.pdf
08/09/2017 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017802s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017802Orig1s032ltr.pdf
06/08/2017 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017802s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017802Orig1s029ltr.pdf
03/06/2002 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
07/08/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
04/03/2000 SUPPL-18 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/017802s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18-782S023.pdf
01/28/1994 SUPPL-17 Labeling

Label is not available on this site.
11/29/1994 SUPPL-16 Labeling

Label is not available on this site.
12/23/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
04/27/1988 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
08/08/1990 SUPPL-13 Labeling

Label is not available on this site.
07/15/1986 SUPPL-11 Labeling

Label is not available on this site.
02/19/1986 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
10/16/1985 SUPPL-9 Labeling

Label is not available on this site.
09/04/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
07/26/1984 SUPPL-7 Labeling

Label is not available on this site.
04/05/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
12/08/1977 SUPPL-3 Labeling

Label is not available on this site.
01/08/1979 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/29/2022 SUPPL-35 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017802s035lbl.pdf
05/08/2019 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017802s034lbl.pdf
03/20/2018 SUPPL-33 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017802s033lbl.pdf
08/09/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017802s032lbl.pdf
06/08/2017 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017802s029lbl.pdf
04/03/2000 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/017802s018lbl.pdf
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