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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075918
Company: MYLAN LABS LTD

Products on ANDA 075918

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE;INJECTION	Prescription	AO	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075918

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2001	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075918_ORIGINAL_APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2011	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
08/19/2008	SUPPL-17	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075918

FLUPHENAZINE DECANOATE

INJECTABLE;INJECTION; 25MG/ML
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	207739	EUGIA PHARMA
FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	071413	FRESENIUS KABI USA
FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	215509	GLAND PHARMA LTD
FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	074531	HIKMA
FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	215365	MSN
FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	075918	MYLAN LABS LTD
FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	203732	PAR STERILE PRODUCTS

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