Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215509
Company: GLAND PHARMA LTD

Products on ANDA 215509

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 215509

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215509

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