Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012145
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROLIXIN FLUPHENAZINE HYDROCHLORIDE 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** ELIXIR;ORAL Discontinued None Yes No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
12/23/1959 ORIG-1 Approval Type 3 - New Dosage Form 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
07/12/2002 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/07/2007 SUPPL-25 Labeling

Label is not available on this site.

12/07/2007 SUPPL-24 Labeling

Label is not available on this site.

12/07/2007 SUPPL-23 Labeling

Label is not available on this site.

12/07/2007 SUPPL-22 Labeling

Label is not available on this site.

12/07/2007 SUPPL-18 Labeling

Label is not available on this site.

12/07/2007 SUPPL-17 Labeling

Label is not available on this site.

02/06/1979 SUPPL-16 Labeling

Label is not available on this site.

12/07/2007 SUPPL-15 Labeling

Label is not available on this site.

12/07/2007 SUPPL-14 Labeling

Label is not available on this site.

12/07/2007 SUPPL-11 Labeling

Label is not available on this site.

12/07/2007 SUPPL-7 Labeling

Label is not available on this site.

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