Drugs@FDA: FDA-Approved Drugs
Company: WYETH PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIPHASIL-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/01/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-50 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019190s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019190Orig1s050ltr.pdf | |
| 05/08/2019 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019190s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017802Orig1s034, 017948Orig1s046, 018926Orig1s013, 019190Orig1s049, 019192Orig1s048ltr.pdf | |
| 08/09/2017 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019190s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019190Orig1s048ltr.pdf | |
| 03/06/2002 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/2000 | SUPPL-36 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/019190s036lbl.pdf | |
| 12/11/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 03/11/1998 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1997 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1996 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1995 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/1995 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 05/03/1995 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 05/27/1994 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/08/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1993 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/09/1993 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/29/1993 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/10/1992 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1991 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1991 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/15/1990 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/18/1990 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1991 | SUPPL-14 | Manufacturing (CMC)-Control |
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. |
||
| 10/27/1987 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/15/1987 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1986 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/07/1991 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/1986 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/20/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/06/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/29/1985 | 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-50 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019190s050lbl.pdf | |
| 05/08/2019 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019190s049lbl.pdf | |
| 08/09/2017 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019190s048lbl.pdf | |
| 03/23/2000 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/019190s036lbl.pdf |