Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018926
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORQUEST FE | ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE | 0.035MG;75MG;1MG | TABLET;ORAL-28 | Discontinued | 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 |
---|---|---|---|---|---|---|---|
07/18/1986 | 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-14 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018926s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018926Orig1s014ltr.pdf | |
05/08/2019 | SUPPL-13 | 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-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017948s045,018926s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018926Orig1s012,017948Orig1s045ltr.pdf | |
08/09/2017 | SUPPL-11 | Labeling-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-10 | Labeling |
Label is not available on this site. |
||
07/31/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/19/1990 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/24/1989 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/17/1989 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
02/22/1989 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/02/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
01/14/1987 | SUPPL-1 | 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-14 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018926s014lbl.pdf | |
05/08/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017948s046,018926s013lbl.pdf | |
03/20/2018 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017948s045,018926s012lbl.pdf | |
08/09/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018926s011,017948s044lbl.pdf |