Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040737
Company: XGEN PHARMS

• Other Important Information from FDA

Products on ANDA 040737

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040737

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/24/2008	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
12/27/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/19/2009	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040737

PROMETHAZINE HYDROCHLORIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	083312	WEST-WARD PHARMS INT
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040737	XGEN PHARMS

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	083312	WEST-WARD PHARMS INT
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040737	XGEN PHARMS