Drugs@FDA: FDA-Approved Drugs
Company: GD SEARLE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORMINEST FE | ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE | 0.035MG;0.5MG;75MG | TABLET;ORAL | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
02/21/1978 | 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-47 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017948s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017948Orig1s047ltr.pdf | |
05/08/2019 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017948s046,018926s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017802Orig1s034, 017948Orig1s046, 018926Orig1s013, 019190Orig1s049, 019192Orig1s048ltr.pdf | |
03/20/2018 | SUPPL-45 | Labeling-Package Insert |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018926Orig1s012,017948Orig1s045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/017948s045,018926s012lbl.pdf |
08/09/2017 | SUPPL-44 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018926s011,017948s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018926Orig1s011,017948Orig1s044ltr.pdf | |
06/02/1995 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
07/31/1992 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/19/1990 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/13/1990 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/24/1989 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/14/1989 | SUPPL-37 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
03/31/1988 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/02/1990 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
11/13/1984 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/12/1984 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
09/27/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/16/1984 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/10/1981 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
08/10/1981 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/10/1981 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
08/10/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/10/1981 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
08/10/1981 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/14/1981 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/18/1980 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/18/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/13/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
05/13/1980 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/13/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
07/18/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/06/1978 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/06/1978 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/26/1978 | 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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-47 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017948s047lbl.pdf | |
05/08/2019 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017948s046,018926s013lbl.pdf | |
08/09/2017 | SUPPL-44 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018926s011,017948s044lbl.pdf |