Etomidate Injection

Brand(s)
Amidate
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-11-04)
Oldest Current Product
1982-09-07
License(s)
NDA, ANDA
RxNORM
INJECTION\ETOMIDATE
FDAOB
INJECTION\INJECTION\ETOMIDATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ETOMIDATE
INTRAVENOUS\INJECTION\ETOMIDATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ETOMIDATE
INTRAVENOUS\INJECTION\ETOMIDATE

product(s) by strength(s)

etomidate 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096695AmidateNDAHospira, Inc.1982-09-07, 2015-09-29ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONNDA018227b7ed5bf8-ba75-44dc-8f81-96b4ad5766be, d0d04291-17d6-403d-b376-38b9d2735fff

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690006ANDAPfizer Labs2012-02-03ETOMIDATEINTRAVENOUSINJECTIONANDA078289a11458d3-12ad-438e-ac48-ef66196b8fe2
2231550160ANDAHeritage Pharmaceuticals Inc.2012-09-13ETOMIDATEINTRAVENOUSINJECTIONANDA204618e3cec780-f4dc-4948-8ffe-fa440ad730ec
3231550522ANDAHeritage Pharmaceuticals Inc.2012-09-13ETOMIDATEINTRAVENOUSINJECTIONANDA204618bbb4e325-52ed-4ecd-9f10-eddfdab31432
4250210674ANDASagent Pharmaceuticals2012-08-10ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONANDA0782896dfd9a2a-540d-4a8e-9b92-b78e89480d39
5400420025ANDAPharmaforce, Inc.ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONANDA07886736ce46e1-8361-4465-b179-8c2d936ed1c0
6658410818ANDACadila Healthcare Limited2015-04-03ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONANDA202360428d51f4-fb7a-4efe-a87e-698d46ef8a24
7674570183ANDAMylan Institutional Llc2013-04-26ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONANDA09129729f81f5d-ec49-41a4-9a22-f24b8e611a7e
8683820545ANDAZydus Pharmaceuticals (Usa) Inc.2015-04-03ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONANDA2023608b71a0a4-d3e7-49a9-b40e-976c94f2eb6b

10 ml etomidate 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004098062AmidateNDAHospira, Inc.1982-09-07ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONNDA018227b7ed5bf8-ba75-44dc-8f81-96b4ad5766be

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170780ANDAAmerican Regent, Inc.2010-06-30ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONANDA078867918590eb-e205-49a4-bdc7-dd61f5cf4c64

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840695AmidateNDAGeneral Injecatables & Vaccines, Inc2010-08-01ETOMIDATEINTRAVENOUSINJECTION, SOLUTION004096695NDA01822790744801-0358-4193-8c3e-46abb2f5d7e8

20 ml etomidate 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004098061AmidateNDAHospira, Inc.1982-09-07ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONNDA018227b7ed5bf8-ba75-44dc-8f81-96b4ad5766be

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170781ANDAAmerican Regent, Inc.2010-06-30ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONANDA078867918590eb-e205-49a4-bdc7-dd61f5cf4c64
2674570456ANDAMylan Institutional Llc2012-02-03ETOMIDATEINTRAVENOUSINJECTION, SOLUTIONANDA0782890bd3695c-6d3d-43dc-97b8-79831a2684f3

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA074593ETOMIDATEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1996-11-04ANDA074593_001Etomidate Prefilled Syringe
2ANDA078289ETOMIDATEMYLAN LABORATORIES LTD2009-01-02ANDA078289_001Etomidate Prefilled Syringe
3ANDA078867ETOMIDATELUITPOLD PHARMACEUTICALS INC2009-12-22ANDA078867_001Etomidate Prefilled Syringe
4ANDA091297ETOMIDATEPAR STERILE PRODUCTS LLC2012-06-20ANDA091297_001Etomidate Prefilled Syringe
5ANDA202360ETOMIDATEZYDUS PHARMACEUTICALS USA INC2014-07-18ANDA202360_001Etomidate Prefilled Syringe
6ANDA204618ETOMIDATEEMCURE PHARMACEUTICALS LTD2014-08-13ANDA204618_001Etomidate Prefilled Syringe
7NDA018227AMIDATEHOSPIRA INC1982-09-07NDA018227_001Etomidate Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074593_001RXETOMIDATE (2MG/ML)INJECTIONFalseAP1996-11-04ETOMIDATE
2ANDA078289_001RXETOMIDATE (2MG/ML)INJECTIONFalseAP2009-01-02ETOMIDATE
3ANDA078867_001RXETOMIDATE (2MG/ML)INJECTIONFalseAP2009-12-22ETOMIDATE
4ANDA091297_001RXETOMIDATE (2MG/ML)INJECTIONFalseAP2012-06-20ETOMIDATE
5ANDA202360_001RXETOMIDATE (2MG/ML)INJECTIONFalseAP2014-07-18ETOMIDATE
6ANDA204618_001RXETOMIDATE (2MG/ML)INJECTIONFalseAP2014-08-13ETOMIDATE
7NDA018227_001RXETOMIDATE (2MG/ML)INJECTIONTrueAP1982-09-07AMIDATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10bd3695c-6d3d-43dc-97b8-79831a2684f3 (view SPL)Etomidate Injection USPprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-09-261674570456
229f81f5d-ec49-41a4-9a22-f24b8e611a7e (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2012-07-313674570183
336ce46e1-8361-4465-b179-8c2d936ed1c0 (view SPL)ETOMIDATE INJECTIONprescriptionHuman PrescriptionPharmaforce, Inc.2010-06-161400420025
4428d51f4-fb7a-4efe-a87e-698d46ef8a24 (view SPL)Etomidate Injection, USPprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2015-04-061658410818
56dfd9a2a-540d-4a8e-9b92-b78e89480d39 (view SPL)Etomidate Injection, USP(2 mg per mL)prescriptionHuman PrescriptionSagent Pharmaceuticals2012-09-252250210674
68b71a0a4-d3e7-49a9-b40e-976c94f2eb6b (view SPL)Etomidate Injection, USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2015-04-031683820545
790744801-0358-4193-8c3e-46abb2f5d7e8 (view SPL)Amidate Etomidate Injection 2 mg/mL Injection, USP 10 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-08-034525840695
8918590eb-e205-49a4-bdc7-dd61f5cf4c64 (view SPL)ETOMIDATE INJECTIONprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE2015-11-064005170780, 005170781
9a11458d3-12ad-438e-ac48-ef66196b8fe2 (view SPL)Etomidate InjectionprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-02-081000690006
10b7ed5bf8-ba75-44dc-8f81-96b4ad5766be (view SPL)Rx onlyAmidateprescriptionHuman PrescriptionHospira, Inc.2015-11-0413004096695, 004098061, 004098062, 004098060Etomidate Prefilled Syringe
11bbb4e325-52ed-4ecd-9f10-eddfdab31432 (view SPL)Rx only2 mg/mLprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-07-091231550522
12d0d04291-17d6-403d-b376-38b9d2735fff (view SPL)Rx onlyAmidateprescriptionHuman PrescriptionHospira, Inc.2015-10-061004096695
13e3cec780-f4dc-4948-8ffe-fa440ad730ec (view SPL)Rx only2 mg/mLprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-03-242231550160

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII