Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089804
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET;ORAL Prescription AB No No
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription AB No No
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG 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
08/12/1988 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
02/23/2017 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-19 Labeling

Label is not available on this site.

05/26/2009 SUPPL-17 Labeling

Label is not available on this site.

09/18/2008 SUPPL-16 Labeling

Label is not available on this site.

08/19/2008 SUPPL-14 Labeling

Label is not available on this site.

12/21/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/10/1995 SUPPL-7 Labeling

Label is not available on this site.

05/10/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/10/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/07/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/11/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FLUPHENAZINE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 089743 LANNETT CO INC
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 089804 MYLAN
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 089586 SANDOZ

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

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 089741 LANNETT
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 089743 LANNETT CO INC
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 089804 MYLAN
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 089586 SANDOZ

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 089742 LANNETT
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 089743 LANNETT CO INC
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 089804 MYLAN
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 089585 SANDOZ
FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 089586 SANDOZ

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