FDA.reportPublic FDA data

Application 204200

Type
NDA
Sponsor
PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADRENALINEPINEPHRINESOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEQ 1MG BASE/ML (EQ 1MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9810AdrenalinepineprineHenry Schein, Inc.NDACurrent
0404-9810AdrenalinepineprineHenry Schein, Inc.NDACurrent
24357-011Epinephrine ProfessionalEpinephrine and Isopropyl AlcoholFocus Health GroupNDACurrent
24357-011Epinephrine ProfessionalEpinephrine and Isopropyl AlcoholFocus Health GroupNDACurrent
24357-011Epinephrine ProfessionalEpinephrine and Isopropyl AlcoholFocus Health GroupNDACurrent
24357-011Epinephrine ProfessionalEpinephrine and Isopropyl AlcoholFocus Health GroupNDACurrent
24357-012Epinephrine Professional EMSEpinephrine Convenience KitFocus Health GroupNDACurrent
24357-012Epinephrine Professional EMSEpinephrine Convenience KitFocus Health GroupNDACurrent
24357-012Epinephrine Professional EMSEpinephrine Convenience KitFocus Health GroupNDACurrent
24357-012Epinephrine Professional EMSEpinephrine Convenience KitFocus Health GroupNDACurrent
42023-159AdrenalinepinephrinePar Pharmaceutical, Inc.NDACurrent
42023-159AdrenalinepinephrinePar Pharmaceutical, Inc.NDACurrent
51662-1290ADRENALIN (EPINEPHRINE)ADRENALIN (EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1290ADRENALIN (EPINEPHRINE)ADRENALIN (EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1290ADRENALIN (EPINEPHRINE)ADRENALIN (EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1290ADRENALIN (EPINEPHRINE)ADRENALIN (EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1290ADRENALIN (EPINEPHRINE)ADRENALIN (EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1507EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1507Epinephrine Convenience KitEpinephrineHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-159AdrenalinepineprineGeneral Injectables and Vaccines, Inc.NDACurrent
52584-159AdrenalinepineprineGeneral Injectables and Vaccines, Inc.NDACurrent
52584-159AdrenalinepineprineGeneral Injectables and Vaccines, Inc.NDACurrent
52584-159AdrenalinepineprineGeneral Injectables and Vaccines, Inc.NDACurrent
52584-159AdrenalinepineprineGeneral Injectables and Vaccines, Inc.NDACurrent
52584-159AdrenalinepineprineGeneral Injectables and Vaccines, Inc.NDACurrent
70518-1342AdrenalinepinephrineREMEDYREPACK INC.NDACurrent
71754-001Certa Dose Epinephrine Convenience KitEpinephrine Convenience KitCerta Dose, Inc.NDACurrent
71754-001Certa Dose Epinephrine Convenience KitEpinephrine Convenience KitCerta Dose, Inc.NDACurrent
71754-001Certa Dose Epinephrine Convenience KitEpinephrine Convenience KitCerta Dose, Inc.NDACurrent
71754-001Certa Dose Epinephrine Convenience KitEpinephrine Convenience KitCD Acquisitions, LLCNDACurrent
71872-7223AdrenalinepinephrineMedical Purchasing Solutions, LLCNDACurrent
71923-100EpinephrineSnap-EMSEpinephrine Convenience KitSnap Medical IndustriesNDACurrent
71923-100EpinephrineSnap-EMSEpinephrine Convenience KitSnap Medical IndustriesNDACurrent
71923-100EpinephrineSnap-EMSEpinephrine Convenience KitSnap Medical IndustriesNDACurrent
71923-100EpinephrineSnap-EMSEpinephrine Convenience KitSnap Medical IndustriesNDACurrent
71923-200EpinephrineSnap-VEpinephrine Convenience KitSnap Medical IndustriesNDACurrent
71923-200EpinephrineSnap-VEpinephrine Convenience KitSnap Medical IndustriesNDACurrent
71923-200EpinephrineSnap-VEpinephrine Convenience KitSnap Medical IndustriesNDACurrent
71923-200EpinephrineSnap-VEpinephrine Convenience KitSnap Medical IndustriesNDACurrent
71923-300Epinephrine Convenience KitEpinephrineSnapSnap Medical Industries, LCCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73120SUPPL2023-01-09
73111SUPPL2023-01-06
61002SUPPL2019-11-20
57498SUPPL2019-02-11
57378SUPPL2019-01-30
49401SUPPL2017-08-15
49338SUPPL2017-08-11
47129SUPPL2017-02-07
47128SUPPL2017-02-07
40365SUPPL2016-05-20
10306SUPPL2016-05-19
44897ORIG2013-08-19
43458ORIG2013-08-19
32524ORIG2012-12-27
40364ORIG2012-12-10