Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016584
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NAVANE THIOTHIXENE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
NAVANE THIOTHIXENE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
NAVANE THIOTHIXENE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
NAVANE THIOTHIXENE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
NAVANE THIOTHIXENE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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

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