FDA.reportPublic FDA data

Application 009866

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOLU-CORTEFHYDROCORTISONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 100MG BASE/VIALYesYes
002SOLU-CORTEFHYDROCORTISONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 250MG BASE/VIALYesYes
003SOLU-CORTEFHYDROCORTISONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 500MG BASE/VIALYesYes
004SOLU-CORTEFHYDROCORTISONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 1GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0005Solu-Cortefhydrocortisone sodium succinatePharmacia & Upjohn Company LLCNDACurrent
0009-0005Solu-Cortefhydrocortisone sodium succinatePharmacia & Upjohn Company LLCNDACurrent
0009-0005Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0005Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0005Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0011Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0011Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0011Solu-Cortefhydrocortisone sodium succinatePharmacia & Upjohn Company LLCNDACurrent
0009-0011Solu-Cortefhydrocortisone sodium succinatePharmacia & Upjohn Company LLCNDACurrent
0009-0011Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0013Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0013Solu-Cortefhydrocortisone sodium succinatePharmacia & Upjohn Company LLCNDACurrent
0009-0013Solu-Cortefhydrocortisone sodium succinatePharmacia & Upjohn Company LLCNDACurrent
0009-0013Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0013Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0016Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0016Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0016Solu-Cortefhydrocortisone sodium succinatePharmacia & Upjohn Company LLCNDACurrent
0009-0016Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0016Solu-Cortefhydrocortisone sodium succinatePharmacia & Upjohn Company LLCNDACurrent
0009-0825Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0825Solu-Cortefhydrocortisone sodium succinatePharmacia & Upjohn Company LLCNDACurrent
0009-0825Solu-Cortefhydrocortisone sodium succinatePharmacia & Upjohn Company LLCNDACurrent
0009-0825Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
0009-0825Solu-Cortefhydrocortisone sodium succinatePharmacia and Upjohn Company LLCNDACurrent
51662-1261SOLU-CORTEFSOLU-CORTEFHF Acquisition Co. LLC, DBA HealthFirstNDACurrent
51662-1261SOLU-CORTEFSOLU-CORTEFHF Acquisition Co. LLC, DBA HealthFirstNDACurrent
51662-1261SOLU-CORTEFSOLU-CORTEFHF Acquisition Co. LLC, DBA HealthFirstNDACurrent
51662-1261SOLU-CORTEFSOLU-CORTEFHF Acquisition Co. LLC, DBA HealthFirstNDACurrent
51662-1262SOLU-CORTEFSOLU-CORTEFHF Acquisition Co. LLC, DBA HealthFirstNDACurrent
51662-1262SOLU-CORTEFSOLU-CORTEFHF Acquisition Co. LLC, DBA HealthFirstNDACurrent
51662-1262SOLU-CORTEFSOLU-CORTEFHF Acquisition Co. LLC, DBA HealthFirstNDACurrent
51662-1262SOLU-CORTEFSOLU-CORTEFHF Acquisition Co. LLC, DBA HealthFirstNDACurrent
55154-3942Solu-Cortefhydrocortisone sodium succinateCardinal HealthNDACurrent
55154-3942Solu-Cortefhydrocortisone sodium succinateCardinal HealthNDACurrent
55154-3942Solu-Cortefhydrocortisone sodium succinateCardinal HealthNDACurrent
55154-3942Solu-Cortefhydrocortisone sodium succinateCardinal Health 107, LLCNDACurrent
55154-3942Solu-Cortefhydrocortisone sodium succinateCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79123SUPPL 2024-07-18
79122SUPPL 2024-07-18
78705SUPPL 2024-06-07
78671SUPPL 2024-06-06
77121SUPPL 2023-12-22
77103SUPPL 2023-12-21
67698SUPPL2021-06-04
67627SUPPL2021-05-28
61017SUPPL2019-11-22
61014SUPPL2019-11-22
45260SUPPL2016-09-09
45259SUPPL2016-09-09
45255SUPPL2016-09-09
45254SUPPL2016-09-09
33008SUPPL2014-07-08
11884SUPPL2014-07-08
10734SUPPL2010-07-01
195SUPPL2010-06-28
11883SUPPL2009-11-09
194SUPPL2009-11-09
33007SUPPL2009-10-05
10733SUPPL2009-10-05