Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016008
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERMITIL FLUPHENAZINE HYDROCHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CONCENTRATE;ORAL Discontinued None No No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
04/07/1965 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
07/26/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1989 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1989 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/19/2000 SUPPL-13 Labeling

Label is not available on this site.

09/11/1986 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/28/1989 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/19/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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