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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202360
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/18/2014 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
03/07/2018 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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 204618 EMCURE PHARMS LTD
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 206126 EUGIA PHARMA
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 209058 GLAND PHARMA LTD
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
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