Drugs@FDA: FDA-Approved Drugs
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOESTRIN FE 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/1973 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/04/2023 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017354s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017354Orig1s055ltr.pdf | |
| 04/29/2022 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017354s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017354Orig1s054ltr.pdf | |
| 08/09/2017 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017876Orig1s036, 017354Orig1s051, 017875s037, 017355Orig1s053ltr.pdf | |
| 01/14/2016 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/2014 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2014 | SUPPL-45 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017354s045lbl.pdf | |
| 05/02/2003 | SUPPL-44 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17354slr044,17355slr046,17875slr032,17876slr031ltr.pdf |
| 03/31/1999 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 01/08/1999 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 11/20/1997 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1997 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1997 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1995 | SUPPL-36 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/02/1994 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/27/1994 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/1996 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1993 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/1996 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 04/22/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 05/17/1989 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/16/1988 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/13/1988 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/22/1986 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/17/1985 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/18/1982 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/22/1977 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/14/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1977 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/11/1975 | SUPPL-10 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/04/2023 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017354s055lbl.pdf | |
| 04/29/2022 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017354s054lbl.pdf | |
| 08/09/2017 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf | |
| 07/31/2014 | SUPPL-45 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017354s045lbl.pdf |