Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089585
Company: SANDOZ

Products on ANDA 089585

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089585

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/1987	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
10/19/2011	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
07/07/2009	SUPPL-19	Labeling		Label is not available on this site.
01/23/2009	SUPPL-18	Labeling		Label is not available on this site.
05/29/2008	SUPPL-14	Labeling		Label is not available on this site.
05/05/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/15/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/08/1998	SUPPL-7	Labeling		Label is not available on this site.
10/08/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/20/1995	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/02/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/01/1988	SUPPL-3	Labeling		Label is not available on this site.
11/01/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/01/1988	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 089585

FLUPHENAZINE HYDROCHLORIDE

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	217410	AJANTA PHARMA LTD
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	213647	AMNEAL
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	216649	APOTEX
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	218055	AUROBINDO PHARMA LTD
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	214534	DR REDDYS
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	216350	GLENMARK PHARMS LTD
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	217189	MSN
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	214674	NOVITIUM PHARMA
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	089585	SANDOZ
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	216891	SANDOZ
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	215674	TARO
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	215848	TWI PHARMS
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	213784	UPSHER SMITH LABS
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	215141	ZAMEER PHARMS
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	214552	ZYDUS LIFESCIENCES