Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089740
Company: LANNETT

Products on ANDA 089740

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089740

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.

Therapeutic Equivalents for ANDA 089740

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	217410	AJANTA PHARMA LTD
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	218173	ALEMBIC
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	213647	AMNEAL
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	218055	AUROBINDO PHARMA LTD
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	214534	DR REDDYS
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	216350	GLENMARK PHARMS LTD
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	218769	HETERO LABS LTD III
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	217189	MSN
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	214674	NOVITIUM PHARMA
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	218283	RISING
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	215674	TARO
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	213784	UPSHER SMITH LABS
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	215141	ZAMEER PHARMS
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET;ORAL	Prescription	No	AB	214552	ZYDUS LIFESCIENCES