Application 204485

Type
NDA
Sponsor
PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VASOSTRICTVASOPRESSINSOLUTION;INTRAVENOUS20UNITS/ML (20UNITS/ML)YesYes
002VASOSTRICTVASOPRESSINSOLUTION;INTRAVENOUS200UNITS/10ML (20UNITS/ML)YesYes
003VASOSTRICTVASOPRESSINSOLUTION;INTRAVENOUS40UNITS/100ML (0.4UNITS/ML)YesYes
004VASOSTRICTVASOPRESSINSOLUTION;INTRAVENOUS60UNITS/100ML (0.6UNITS/ML)YesYes
005VASOSTRICTVASOPRESSINSOLUTION;INTRAVENOUS20UNITS/100ML (0.2UNITS/ML)YesYes
006VASOSTRICTVASOPRESSINSOLUTION;INTRAVENOUS50UNITS/50ML (1UNITS/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42023-164VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-164VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-164VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-164VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-164VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-164VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-164VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-164VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-164VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-164VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-190VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-190VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-190VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-190VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-190VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-190VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-190VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-190VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-190VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-190VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-219VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-219VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-219VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-219VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-219VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-220VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-220VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-220VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-220VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-220VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-237VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
42023-237VasostrictVasopressinPar Pharmaceutical, Inc.NDACurrent
43598-085VasopressinVasopressinDR. REDDYS LABORATORIES INCNDACurrent
51662-1314VASOPRESSINVASOPRESSINHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1314VASOPRESSINVASOPRESSINHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1314VASOPRESSINVASOPRESSINHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1314VASOPRESSINVASOPRESSINHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1607VASOPRESSINVASOPRESSINHF Acquisition Co LLC, DBA HealthFirstNDACurrent
55150-371VasopressinVasopressinAuroMedics Pharma LLCNDACurrent
71872-7014VasostrictVasopressinMedical Purchasin Solutions, LLCNDACurrent
71872-7014VasostrictVasopressinMedical Purchasin Solutions, LLCNDACurrent
71872-7264VasostrictVasopressinMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75020SUPPL 2023-08-09
74970SUPPL 2023-08-09
74477SUPPL 2023-04-12
74476SUPPL 2023-04-12
72830SUPPL2022-12-08
72812SUPPL2022-12-07
72720SUPPL2022-11-27
72709SUPPL2022-11-25
72165SUPPL2022-09-27
72164SUPPL2022-09-27
68151SUPPL2021-07-21
68141SUPPL2021-07-21
67017SUPPL2021-04-09
67014SUPPL2021-04-09
66916SUPPL2021-03-30
66902SUPPL2021-03-29
66785SUPPL2021-03-16
64130SUPPL2020-07-30
64129SUPPL2020-07-30
61979SUPPL2020-02-27
61955SUPPL2020-02-25
58765SUPPL2019-05-17
58727SUPPL2019-05-15
48858SUPPL2017-06-29
48420SUPPL2017-05-17
47991SUPPL2017-04-12
47990SUPPL2017-04-12
19567SUPPL2015-05-07
10348SUPPL2015-05-07
24471ORIG2015-01-28
22958ORIG2015-01-28
19566SUPPL2015-01-07
19565ORIG2014-09-03
10347ORIG2014-04-18