Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012034
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERMITIL FLUPHENAZINE HYDROCHLORIDE 0.25MG TABLET;ORAL Discontinued None No No
PERMITIL FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET;ORAL Discontinued None No No
PERMITIL FLUPHENAZINE HYDROCHLORIDE 5MG TABLET;ORAL Discontinued None No No
PERMITIL FLUPHENAZINE HYDROCHLORIDE 10MG TABLET;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
09/09/1959 ORIG-1 Approval Type 1 - New Molecular Entity 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
10/18/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/2000 SUPPL-15 Labeling

Label is not available on this site.

11/12/2002 SUPPL-11 Labeling

Label is not available on this site.

11/12/2002 SUPPL-10 Labeling

Label is not available on this site.

11/12/2002 SUPPL-9 Labeling

Label is not available on this site.

11/12/2002 SUPPL-7 Labeling

Label is not available on this site.

11/12/2002 SUPPL-4 Labeling

Label is not available on this site.

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