Application 204640

Type
NDA
Sponsor
PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADRENALINEPINEPHRINESOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEQ 30MG BASE/30ML (EQ 1MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42023-168AdrenalinepinephrinePar Pharmaceutical, Inc.NDACurrent
42023-168AdrenalinepinephrinePar Pharmaceutical, Inc.NDACurrent
42023-168AdrenalinepinephrinePar Pharmaceutical, Inc.NDACurrent
42023-168AdrenalinepinephrinePar Pharmaceutical, Inc.NDACurrent
42023-168AdrenalinepinephrinePar Pharmaceutical, Inc.NDACurrent
42023-168AdrenalinepinephrinePar Pharmaceutical, Inc.NDACurrent
51662-1307ADRENALIN(R)ADRENALIN(R)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1307ADRENALIN(R)ADRENALIN(R)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1307ADRENALIN(R)ADRENALIN(R)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1307ADRENALIN(R)ADRENALIN(R)HF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85856SUPPL 2026-05-08
73121SUPPL2023-01-09
73113SUPPL2023-01-06
61003SUPPL2019-11-20
57497SUPPL2019-02-11
57379SUPPL2019-01-30
49402SUPPL2017-08-15
49339SUPPL2017-08-11
40405SUPPL2016-05-20
10374SUPPL2016-05-19
10373SUPPL2015-12-30
40404SUPPL2015-12-28
43471ORIG2014-03-06
24475ORIG2014-03-06
10372ORIG2013-12-20
40403ORIG2013-12-19