Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018227
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/07/1982 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/27/2017 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018227s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018227Orig1s032ltr.pdf
07/03/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/03/2002 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/06/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/26/1999 SUPPL-12 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018227_s012_AmidateTOC.cfm
09/29/1998 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/30/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1994 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/25/1988 SUPPL-5 Labeling

Label is not available on this site.

06/16/1986 SUPPL-4 Labeling

Label is not available on this site.

05/30/1985 SUPPL-3 Labeling

Label is not available on this site.

05/30/1985 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/15/1986 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/27/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018227s032lbl.pdf

AMIDATE

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 206126 AUROBINDO PHARMA LTD
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 204618 EMCURE PHARMS LTD
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 209058 GLAND PHARMA LTD
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 202354 HIKMA FARMACEUTICA
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 078867 LUITPOLD
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 078289 MYLAN LABS LTD
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 201044 MYLAN LABS LTD
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 091297 PAR STERILE PRODUCTS
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 074593 WEST-WARD PHARMS INT
ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE;INJECTION Prescription No AP 202360 ZYDUS PHARMS USA INC

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