Drugs@FDA: FDA-Approved Drugs
Company: WYETH PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUINIDEX | QUINIDINE SULFATE | 300MG | TABLET, EXTENDED RELEASE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/21/1962 | 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 |
|---|---|---|---|---|---|
| 08/16/2001 | SUPPL-49 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/12796s49lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12796s49ltr.pdf | |
| 06/24/1998 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 01/13/1998 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1995 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 05/02/1988 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/25/1988 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/01/1987 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 06/12/1987 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 04/22/1986 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/12/1986 | SUPPL-39 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/02/1988 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 07/22/1985 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/07/1985 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 07/22/1985 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1984 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/31/1984 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/04/1984 | SUPPL-32 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/04/1984 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/04/1984 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 10/26/1982 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/08/1982 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/04/1981 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1981 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1984 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/19/1980 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/19/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/21/1979 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/19/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/1978 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/11/1977 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/1977 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/11/1977 | SUPPL-11 | Efficacy |
Label is not available on this site. |
||
| 10/11/1977 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/16/2001 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/12796s49lbl.pdf |