bivalirudin 250 MG Injection

RxCUI
308769
RxNorm name
bivalirudin 250 MG Injection
Display name
bivalirudin 250 MG Injection
Full name
bivalirudin 250 MG Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIVALIRUDINBIVALIRUDINEugia US LLCe574d04f-67b4-4a84-9d66-8c2d54f951202026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 308769
bivalirudinBIVALIRUDINCivica, Inc.19a4afc5-151d-4d3c-bfef-48aa8797d6952025-09-10Warnings, Adverse reactionsExact identifier
rxcui: 308769
BivalirudinBIVALIRUDINFresenius Kabi USA, LLC50975be1-6d1f-497c-b989-1825a0fae1a72025-08-27Warnings, Adverse reactionsExact identifier
rxcui: 308769
BivalirudinBIVALIRUDINFresenius Kabi USA, LLCaf943fa0-ab0f-4b62-9ff0-54ee24cdb7722025-05-08Warnings, Adverse reactionsExact identifier
rxcui: 308769
BivalirudinBIVALIRUDINMylan Institutional LLC95d150e7-f152-4091-b831-e469c9578a542025-03-24Warnings, Adverse reactionsExact identifier
rxcui: 308769
BivalirudinBIVALIRUDINHainan Shuangcheng Pharmaceuticals Co., Ltd.61de12ff-e280-4bab-9804-43869ec45fa72024-12-23Warnings, Adverse reactionsExact identifier
rxcui: 308769
BivalirudinBIVALIRUDINAccord Healthcare, Inc.c20969cb-72d4-469b-9bd8-332250d896c32024-08-15Warnings, Adverse reactionsExact identifier
rxcui: 308769
BIVALIRUDINBIVALIRUDINMeitheal Pharmaceuticals Inc.26fb46f6-0088-42b8-b6f2-c672247768032024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 308769
BivalirudinBIVALIRUDINAvenacy, Inc.42aa2630-83d6-433d-8277-0f672cf8d71d2023-10-20Warnings, Adverse reactionsExact identifier
rxcui: 308769
bivalirudinBIVALIRUDINSlate Run Pharmaceuticals, LLC5d9a45c6-e234-4d56-9132-5e24e65852e62021-06-09Warnings, Adverse reactionsExact identifier
rxcui: 308769
BIVALIRUDINBIVALIRUDINMeitheal Pharmaceuticals Inc.4119b710-ef30-4e3e-b99a-38e42b4b3fca2021-06-08Warnings, Adverse reactionsExact identifier
rxcui: 308769
bivalirudinBIVALIRUDINSandoz Incce56f806-7845-429d-a1ce-c2dbf79b22eb2019-09-30Warnings, Adverse reactionsExact identifier
rxcui: 308769
BivalirudinBIVALIRUDINDr. Reddy's Laboratories Limited19beb2ae-6064-3c24-fe50-0cee868969792019-07-16Warnings, Adverse reactionsExact identifier
rxcui: 308769

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
19beb2ae-6064-3c24-fe50-0cee86896979bivalirudin 50 MG/ML InjectionSY10These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020190716
19beb2ae-6064-3c24-fe50-0cee86896979bivalirudin 250 MG InjectionPSN10These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020190716
19beb2ae-6064-3c24-fe50-0cee86896979bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY10These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020190716
19beb2ae-6064-3c24-fe50-0cee86896979bivalirudin 250 MG InjectionSCD10These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020190716
95d150e7-f152-4091-b831-e469c9578a54bivalirudin 50 MG/ML InjectionSY8These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250324
95d150e7-f152-4091-b831-e469c9578a54bivalirudin 250 MG InjectionPSN8These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250324
95d150e7-f152-4091-b831-e469c9578a54bivalirudin 250 MG InjectionSCD8These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250324
95d150e7-f152-4091-b831-e469c9578a54bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY8These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250324
e574d04f-67b4-4a84-9d66-8c2d54f95120bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY8These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020241210
e574d04f-67b4-4a84-9d66-8c2d54f95120bivalirudin 250 MG InjectionPSN8These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020241210
e574d04f-67b4-4a84-9d66-8c2d54f95120bivalirudin 250 MG InjectionSCD8These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020241210
e574d04f-67b4-4a84-9d66-8c2d54f95120bivalirudin 50 MG/ML InjectionSY8These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020241210
c20969cb-72d4-469b-9bd8-332250d896c3bivalirudin 50 MG/ML InjectionSY7These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020240815
c20969cb-72d4-469b-9bd8-332250d896c3bivalirudin 250 MG InjectionPSN7These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020240815
c20969cb-72d4-469b-9bd8-332250d896c3bivalirudin 250 MG InjectionSCD7These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020240815
c20969cb-72d4-469b-9bd8-332250d896c3bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY7These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020240815
af943fa0-ab0f-4b62-9ff0-54ee24cdb772bivalirudin 50 MG/ML InjectionSY5These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250508
af943fa0-ab0f-4b62-9ff0-54ee24cdb772bivalirudin 250 MG InjectionPSN5These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250508
af943fa0-ab0f-4b62-9ff0-54ee24cdb772bivalirudin 250 MG InjectionSCD5These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250508
af943fa0-ab0f-4b62-9ff0-54ee24cdb772bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY5These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250508
61de12ff-e280-4bab-9804-43869ec45fa7bivalirudin 250 MG InjectionPSN5These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020241223
61de12ff-e280-4bab-9804-43869ec45fa7bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY5These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020241223
61de12ff-e280-4bab-9804-43869ec45fa7bivalirudin 250 MG InjectionSCD5These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020241223
61de12ff-e280-4bab-9804-43869ec45fa7bivalirudin 50 MG/ML InjectionSY5These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020241223
50975be1-6d1f-497c-b989-1825a0fae1a7bivalirudin 250 MG InjectionPSN4These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250827
50975be1-6d1f-497c-b989-1825a0fae1a7bivalirudin 50 MG/ML InjectionSY4These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250827
50975be1-6d1f-497c-b989-1825a0fae1a7bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY4These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250827
50975be1-6d1f-497c-b989-1825a0fae1a7bivalirudin 250 MG InjectionSCD4These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250827
ce56f806-7845-429d-a1ce-c2dbf79b22ebbivalirudin 50 MG/ML InjectionSY4These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020190930
ce56f806-7845-429d-a1ce-c2dbf79b22ebbivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY4These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020190930
ce56f806-7845-429d-a1ce-c2dbf79b22ebbivalirudin 250 MG InjectionPSN4These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020190930
ce56f806-7845-429d-a1ce-c2dbf79b22ebbivalirudin 250 MG InjectionSCD4These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020190930
19a4afc5-151d-4d3c-bfef-48aa8797d695bivalirudin 50 MG/ML InjectionSY2These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250910
19a4afc5-151d-4d3c-bfef-48aa8797d695bivalirudin 250 MG InjectionSCD2These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250910
19a4afc5-151d-4d3c-bfef-48aa8797d695bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY2These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250910
19a4afc5-151d-4d3c-bfef-48aa8797d695bivalirudin 250 MG InjectionPSN2These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020250910
4119b710-ef30-4e3e-b99a-38e42b4b3fcabivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY2These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020210608
4119b710-ef30-4e3e-b99a-38e42b4b3fcabivalirudin 50 MG/ML InjectionSY2These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020210608
4119b710-ef30-4e3e-b99a-38e42b4b3fcabivalirudin 250 MG InjectionPSN2These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020210608
4119b710-ef30-4e3e-b99a-38e42b4b3fcabivalirudin 250 MG InjectionSCD2These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020210608
26fb46f6-0088-42b8-b6f2-c67224776803bivalirudin 250 MG InjectionSCD1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020240404
26fb46f6-0088-42b8-b6f2-c67224776803bivalirudin 50 MG/ML InjectionSY1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020240404
26fb46f6-0088-42b8-b6f2-c67224776803bivalirudin 250 MG InjectionPSN1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020240404
26fb46f6-0088-42b8-b6f2-c67224776803bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020240404
13162448-1148-392b-e063-6394a90a4ebbbivalirudin 50 MG/ML InjectionSY1BIVALIRUDIN for injection, for intravenous use (Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC) These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. Initial U.S. Approval: 200020240307
13162448-1148-392b-e063-6394a90a4ebbbivalirudin 250 MG InjectionPSN1BIVALIRUDIN for injection, for intravenous use (Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC) These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. Initial U.S. Approval: 200020240307
13162448-1148-392b-e063-6394a90a4ebbbivalirudin 250 MG InjectionSCD1BIVALIRUDIN for injection, for intravenous use (Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC) These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. Initial U.S. Approval: 200020240307
13162448-1148-392b-e063-6394a90a4ebbbivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY1BIVALIRUDIN for injection, for intravenous use (Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC) These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. Initial U.S. Approval: 200020240307
42aa2630-83d6-433d-8277-0f672cf8d71dbivalirudin 250 MG InjectionSCD1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020231020
42aa2630-83d6-433d-8277-0f672cf8d71dbivalirudin 250 MG InjectionPSN1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020231020
42aa2630-83d6-433d-8277-0f672cf8d71dbivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020231020
42aa2630-83d6-433d-8277-0f672cf8d71dbivalirudin 50 MG/ML InjectionSY1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 200020231020
5d9a45c6-e234-4d56-9132-5e24e65852e6bivalirudin 50 MG/ML InjectionSY1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. Initial U.S. Approval: 200020210609
5d9a45c6-e234-4d56-9132-5e24e65852e6bivalirudin 250 MG InjectionPSN1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. Initial U.S. Approval: 200020210609
5d9a45c6-e234-4d56-9132-5e24e65852e6bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSY1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. Initial U.S. Approval: 200020210609
5d9a45c6-e234-4d56-9132-5e24e65852e6bivalirudin 250 MG InjectionSCD1These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. Initial U.S. Approval: 200020210609