Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016904
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAVANE THIOTHIXENE HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
NAVANE THIOTHIXENE HYDROCHLORIDE EQ 10MG BASE/VIAL INJECTABLE;INJECTION 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
08/19/1971 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-34 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-33 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
08/02/1996 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.
07/25/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
07/15/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
07/19/1989 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
12/10/1987 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
08/26/1985 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/17/1984 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/08/1983 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/10/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
01/18/1982 SUPPL-14 Labeling

Label is not available on this site.
01/18/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
12/10/1980 SUPPL-11 Labeling

Label is not available on this site.
06/02/1981 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
09/21/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
10/12/1979 SUPPL-8 Manufacturing (CMC)-Formulation

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-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016584s059lbl.pdf
04/07/2008 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016584057,016758s019,016904s033lbl.pdf

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