Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016727
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROLIXIN DECANOATE FLUPHENAZINE DECANOATE 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/20/1972 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
10/04/2002 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

09/17/2001 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

08/16/1994 SUPPL-51 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/11/1994 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1996 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/2009 SUPPL-46 Labeling

Label is not available on this site.

03/13/2009 SUPPL-45 Labeling

Label is not available on this site.

06/15/1987 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/2009 SUPPL-41 Labeling

Label is not available on this site.

03/13/2009 SUPPL-40 Labeling

Label is not available on this site.

09/19/1986 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

03/13/2009 SUPPL-38 Labeling

Label is not available on this site.

10/23/1985 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/12/1985 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/2009 SUPPL-35 Labeling

Label is not available on this site.

06/29/1984 SUPPL-34 Labeling

Label is not available on this site.

05/11/1984 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/21/1984 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1985 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/03/1983 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/04/1982 SUPPL-28 Labeling

Label is not available on this site.

08/04/1982 SUPPL-27 Labeling

Label is not available on this site.

02/04/1982 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/10/1981 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-23 Labeling

Label is not available on this site.

04/16/1981 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/1981 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/09/1981 SUPPL-20 Labeling

Label is not available on this site.

04/28/1980 SUPPL-19 Labeling

Label is not available on this site.

12/20/1979 SUPPL-17 Labeling

Label is not available on this site.

12/20/1979 SUPPL-16 Labeling

Label is not available on this site.

01/04/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-14 Labeling

Label is not available on this site.

03/13/2009 SUPPL-11 Labeling

Label is not available on this site.

02/06/1979 SUPPL-10 Labeling

Label is not available on this site.

11/21/1978 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/13/2009 SUPPL-8 Labeling

Label is not available on this site.

03/13/2009 SUPPL-6 Labeling

Label is not available on this site.

09/25/1974 SUPPL-4

Label is not available on this site.

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