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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017031
Company: LABORATOIRE HRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPILL NORGESTREL 0.075MG TABLET;ORAL Over-the-counter None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/23/1973 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
03/11/2024 SUPPL-43 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017031Orig1s042, s043lbl.pdf
03/11/2024 SUPPL-42 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017031Orig1s042, s043lbl.pdf
07/13/2023 SUPPL-41 Efficacy-Rx To OTC Switch Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017031s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017031Orig1s041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/017031Orig1s041SumR.pdf
08/15/2017 SUPPL-36 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017031Orig1s035,s036ltr.pdf
08/15/2017 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017031Orig1s035,s036ltr.pdf
07/20/2004 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17031s034ltr.pdf
03/06/2002 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
07/08/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
01/18/1996 SUPPL-27 Labeling

Label is not available on this site.
11/29/1994 SUPPL-26 Labeling

Label is not available on this site.
01/21/1993 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
08/19/1992 SUPPL-24 Labeling

Label is not available on this site.
10/06/1988 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
09/01/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
04/07/1987 SUPPL-20 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
10/16/1985 SUPPL-19 Labeling

Label is not available on this site.
05/03/1984 SUPPL-18 Labeling

Label is not available on this site.
12/22/1983 SUPPL-17 Labeling

Label is not available on this site.
06/03/1982 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/15/1980 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
11/20/1978 SUPPL-7 Labeling

Label is not available on this site.
08/15/1977 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.
12/08/1977 SUPPL-4 Labeling

Label is not available on this site.
12/01/1976 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
01/15/1976 SUPPL-2 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
03/11/2024 SUPPL-43 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017031Orig1s042, s043lbl.pdf
03/11/2024 SUPPL-42 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017031Orig1s042, s043lbl.pdf
07/13/2023 SUPPL-41 Efficacy-Rx To OTC Switch Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017031s041lbl.pdf
08/15/2017 SUPPL-36 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf
08/15/2017 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf

OPILL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 0.075MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OPILL NORGESTREL 0.075MG TABLET;ORAL Over-the-counter Yes 017031 LABORATOIRE HRA
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