Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016758
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAVANE THIOTHIXENE HYDROCHLORIDE EQ 5MG BASE/ML CONCENTRATE;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
04/06/1970 ORIG-1 Approval Type 2 - New Active Ingredient 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
07/19/2009 SUPPL-20 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
04/07/2008 SUPPL-19 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-17 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf
07/31/2001 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf
07/31/2001 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16584s55ltr.pdf
12/10/1980 SUPPL-7 Labeling

Label is not available on this site.

05/01/1975 SUPPL-4 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
07/19/2009 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf
04/07/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf
05/19/2003 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16584s55s47lbl.pdf

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