Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAVANE | THIOTHIXENE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
NAVANE | THIOTHIXENE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
NAVANE | THIOTHIXENE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
NAVANE | THIOTHIXENE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
NAVANE | THIOTHIXENE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
07/24/1967 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
12/01/2010 | SUPPL-60 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016584s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016584s060ltr.pdf | |
07/19/2009 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016584s059,016758s020,016904s034ltr.pdf | |
08/14/2008 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s058ltr.pdf | |
04/07/2008 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016584s057, 016758s019, 016904s033ltr.pdf | |
05/19/2003 | SUPPL-56 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf | |
07/31/2001 | SUPPL-55 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf |
02/28/2001 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/27/2000 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/26/1994 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/31/2001 | SUPPL-47 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf | |
06/26/1984 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/21/1984 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/10/1982 | SUPPL-42 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/21/1981 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/10/1981 | SUPPL-38 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
09/24/1982 | SUPPL-37 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
12/10/1980 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
10/08/1980 | SUPPL-35 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
09/15/1980 | SUPPL-34 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
10/03/1979 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/11/1978 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
12/08/1978 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/07/1978 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
07/07/1978 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/18/1977 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
07/29/1976 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/01/1975 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/24/1974 | SUPPL-20 | 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 |
---|---|---|---|---|---|
12/01/2010 | SUPPL-60 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016584s060lbl.pdf | |
07/19/2009 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf | |
08/14/2008 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584s058lbl.pdf | |
04/07/2008 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf | |
05/19/2003 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf | |
07/31/2001 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf |