Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089740
Company: LANNETT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET;ORAL Prescription AB 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
08/25/1988 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
12/03/2010 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

03/12/2010 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

01/23/2009 SUPPL-22 Labeling

Label is not available on this site.

07/25/2008 SUPPL-21 Labeling

Label is not available on this site.

04/12/2001 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

04/12/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/09/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/31/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/27/1993 SUPPL-11 Labeling

Label is not available on this site.

11/26/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/23/1990 SUPPL-5 Bioequivalence

Label is not available on this site.

12/19/1988 SUPPL-1 Bioequivalence

Label is not available on this site.

FLUPHENAZINE HYDROCHLORIDE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 089740 LANNETT
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 089743 LANNETT CO INC
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 089804 MYLAN
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 089586 SANDOZ

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