Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209058
Company: GLAND

Products on ANDA 209058

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETOMIDATE	ETOMIDATE	2MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/18/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209058Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2018	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209058

ETOMIDATE

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMIDATE	ETOMIDATE	2MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018227	HOSPIRA
ETOMIDATE	ETOMIDATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215028	CAPLIN
ETOMIDATE	ETOMIDATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206126	EUGIA PHARMA
ETOMIDATE	ETOMIDATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209058	GLAND
ETOMIDATE	ETOMIDATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074593	HIKMA
ETOMIDATE	ETOMIDATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	202354	HIKMA
ETOMIDATE	ETOMIDATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	201044	MYLAN LABS LTD
ETOMIDATE	ETOMIDATE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	202360	ZYDUS PHARMS