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ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |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