Drugs@FDA: FDA-Approved Drugs
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ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-41 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018782s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018782Orig1s041ltr.pdf | |
05/07/2021 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018782s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018782Orig1s040ltr.pdf | |
03/13/2019 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018782s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018782Orig1s039ltr.pdf | |
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. |
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04/27/1988 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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08/08/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
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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. |
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12/20/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
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02/19/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/06/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
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07/29/1985 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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. |
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03/12/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018782s041lbl.pdf | |
04/29/2022 | SUPPL-41 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018782s041lbl.pdf | |
05/07/2021 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018782s040lbl.pdf | |
03/13/2019 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018782s039lbl.pdf | |
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 |