Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040146
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG/5ML ELIXIR;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/21/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

12/03/2009 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

03/12/2009 SUPPL-2 Labeling

Label is not available on this site.

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