Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016110
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROLIXIN ENANTHATE FLUPHENAZINE ENANTHATE 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No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
03/15/1967 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/21/1992 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/26/1989 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1986 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/13/1986 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

06/21/1982 SUPPL-29 Labeling

Label is not available on this site.

02/04/1982 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/11/1981 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1981 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1981 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1981 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/09/1981 SUPPL-21 Labeling

Label is not available on this site.

01/04/1980 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1979 SUPPL-19 Labeling

Label is not available on this site.

12/15/1978 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/08/1977 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

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