Water Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Diagnostic Green Gmbh (2015-10-30)
Oldest Current Product
1971-06-23
License(s)
NDA, ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\WATER
FDAOB
INJECTION\INJECTION\EPOPROSTENOL SODIUM\rdfq
INJECTION\INJECTION\INDOCYANINE GREEN\rdfq
N/A\LIQUID\STERILE WATER FOR INJECTION\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\WATER
INTRAVENOUS\INJECTION, SOLUTION\INDOCYANINE GREEN: WATER
INTRAVENOUS\INJECTION, SOLUTION\WATER
INTRAVENOUS\INJECTION\WATER
INTRAVENOUS\LIQUID\WATER
INTRAVENOUS\SOLUTION\WATER
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\WATER
INTRAVENOUS\INJECTION, SOLUTION\INDOCYANINE GREEN ACID FORM: WATER
INTRAVENOUS\INJECTION, SOLUTION\INDOCYANINE GREEN: INDOCYANINE GREEN ACID FORM: WATER
INTRAVENOUS\INJECTION, SOLUTION\WATER
INTRAVENOUS\INJECTION\WATER
INTRAVENOUS\LIQUID\WATER
INTRAVENOUS\SOLUTION\WATER

product(s) by strength(s)

water 1000 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002647850NDAB. Braun Medical Inc.1988-02-24WATERINTRAVENOUSINJECTIONNDA0196338fc8d87a-3951-4ac5-97df-c161ffc90475
2004091590UNAPPROVED DRUG OTHER MARKETING CATEGORYHospira, Inc.1971-06-23WATERINTRAVENOUSLIQUIDdd05b020-9be7-4aca-a1f4-4f57c0efb8ea
3004097118NDAHospira, Inc.1989-12-26WATERINTRAVENOUSINJECTION, SOLUTIONNDA019869fad47f9a-26d5-4a5e-4faa-2295e97033f6
4004097990NDAHospira, Inc.2011-04-01, 2012-04-04WATERINTRAVENOUSINJECTION, SOLUTIONNDA018233107a336c-9195-461b-f897-a920874284b3, 7d03bbfc-927f-4958-6bb4-be8864ddc35c
5005173005UNAPPROVED DRUG OTHER MARKETING CATEGORYAmerican Regent, Inc.1990-09-30WATERINTRAVENOUSINJECTION, SOLUTION78b35864-4bbc-4759-a5c1-7e4f25e22932
6005173010UNAPPROVED DRUG OTHER MARKETING CATEGORYAmerican Regent, Inc.1990-09-30WATERINTRAVENOUSINJECTION, SOLUTION78b35864-4bbc-4759-a5c1-7e4f25e22932

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416147ANDAWest-Ward Pharmaceuticals Corp.2015-09-03WATERINTRAMUSCULARINJECTION, SOLUTIONANDA20636978ef7ad3-451d-43d0-a9b6-5cf0aadca003
2007039258ANDATeva Parenteral Medicines, Inc2008-04-23WATERINTRAVENOUSINJECTIONANDA07839656733651-d331-4e69-a6a3-303756ccc53c
3254310424ANDAPulsion Medical Systems Se2008-01-01INDOCYANINE GREEN, WATERINTRAVENOUSINJECTION, SOLUTIONANDA040811b3d23a29-6413-4fe0-96ec-858d15659aa2
4701000424ANDADiagnostic Green Gmbh2008-01-01INDOCYANINE GREEN, WATERINTRAVENOUSINJECTION, SOLUTIONANDA040811a6f24787-c243-445a-9c55-7c7479b292d9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490739NDARemedyrepack Inc.2013-06-10, 2013-10-31WATERINTRAMUSCULARINJECTION, SOLUTION004093977NDA01880244d7a7d9-0e6e-4c79-aa87-11db6869790b, 47fc051c-b932-47a6-88d1-5a696ec8e07c, 6831bd7c-51c6-42fc-9f81-7febf6af4ee2
2521250661NDARemedyrepack Inc.2013-07-03WATERINTRAMUSCULARINJECTION, SOLUTION004093977NDA018802abc12e43-f4a2-4097-a1be-b24b4a20c04d
3525840027UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-09-01WATERINTRAVENOUSSOLUTION004094027aa184016-e1fa-4326-b2a4-2e54c6caeac1
4525840887NDAGeneral Injecatables & Vaccines, Inc2010-03-01WATERINTRAVENOUSSOLUTION004094887NDA018801c6eed2ad-25f3-479e-9c28-1945eea88f8d
5525840977NDAGeneral Injecatables & Vaccines, Inc2010-08-01WATERINTRAMUSCULARINJECTION, SOLUTION004093977NDA01880221eadcab-0f74-4d3f-9bcc-6cf7e260fdd0
6545692222UNAPPROVED DRUG OTHER MARKETING CATEGORYA-S Medication Solutions Llc1990-09-30WATERINTRAVENOUSINJECTION, SOLUTION005173005c9bdc472-5489-45bf-b45b-9a3fafd0d291
7551542379NDACardinal Health2011-09-15WATERINTRAMUSCULARINJECTION, SOLUTION004094887NDA0188012afa9944-8b5d-4a41-bb39-c43412d82e10
8616993977NDAUs Medsource, Llc2014-07-07WATERINTRAMUSCULARINJECTION, SOLUTION004093977NDA018802ccadcf46-6a6f-436b-9bbc-17e2983a335f
9617860349UNAPPROVED DRUG OTHER MARKETING CATEGORYRemedyrepack Inc.2015-06-18WATERINTRAVENOUSINJECTION, SOLUTION005173020ce4113dc-1dc6-41d4-ba36-5c512667ba3c
10647254887NDATya Pharmaceuticals2011-09-15WATERINTRAMUSCULARINJECTION, SOLUTION004094887NDA01880101174c59-da71-4470-badc-bbd76cb2b8db

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA040811INDOCYANINE GREENPULSION MEDICAL SYSTEMS AG2007-11-21ANDA040811_001
2ANDA077393STERILE WATER FOR INJECTION IN PLASTIC CONTAINERTARO PHARMACEUTICALS IRELAND LTD2006-08-11ANDA077393_001
3ANDA078396EPOPROSTENOL SODIUMTEVA PHARMACEUTICALS USA2008-04-23ANDA078396_001, ANDA078396_002Epoprostenol Injectable Solution
4ANDA088400STERILE WATER FOR INJECTION IN PLASTIC CONTAINERFRESENIUS KABI USA LLC1984-01-16ANDA088400_001
5ANDA089099BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINERTrueABRAXIS PHARMACEUTICAL PRODUCTS1987-12-29ANDA089099_001
6ANDA089100BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINERTrueABRAXIS PHARMACEUTICAL PRODUCTS1987-12-29ANDA089100_001
7ANDA206369STERILE WATER FOR INJECTIONEUROHEALTH INTERNATIONAL SARL2015-09-02ANDA206369_001
8NDA011525IC-GREENAKORN INCNDA011525_001, NDA011525_002, NDA011525_003, NDA011525_004
9NDA018233STERILE WATER FOR INJECTION IN PLASTIC CONTAINERHOSPIRA INCNDA018233_001
10NDA018632STERILE WATER FOR INJECTION IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1982-06-30NDA018632_001, NDA018632_002
11NDA018801STERILE WATER FOR INJECTION IN PLASTIC CONTAINERHOSPIRA INC1982-10-27NDA018801_001
12NDA018802BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINERHOSPIRA INC1982-10-27NDA018802_001
13NDA019077STERILE WATER FOR INJECTION IN PLASTIC CONTAINERTrueB BRAUN MEDICAL INC1984-03-02NDA019077_001
14NDA019633STERILE WATER FOR INJECTION IN PLASTIC CONTAINERB BRAUN MEDICAL INC1988-02-29NDA019633_001
15NDA019869STERILE WATER FOR INJECTION IN PLASTIC CONTAINERHOSPIRA INC1989-12-26NDA019869_001
16NDA020444FLOLANGLAXOSMITHKLINE LLC1995-09-20NDA020444_001, NDA020444_002Epoprostenol Injectable Solution
17NDA022260VELETRIACTELION PHARMACEUTICALS LTD2008-06-27p8318802, SUBSTANCE
p8598227
NDA022260_001, NDA022260_002Epoprostenol Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040811_001RXINDOCYANINE GREEN (25MG/VIAL)INJECTIONFalseAP2007-11-21INDOCYANINE GREEN
2ANDA077393_001RXSTERILE WATER FOR INJECTION (100%)LIQUIDFalseAP2006-08-11STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
3ANDA078396_001RXEPOPROSTENOL SODIUM (EQ 0.5MG BASE/VIAL)INJECTIONFalseAP2008-04-23EPOPROSTENOL SODIUM
4ANDA078396_002RXEPOPROSTENOL SODIUM (EQ 1.5MG BASE/VIAL)INJECTIONFalseAP2008-04-23EPOPROSTENOL SODIUM
5ANDA088400_001RXSTERILE WATER FOR INJECTION (100%)LIQUIDFalseAP1984-01-16STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
6ANDA089099_001discontinuedSTERILE WATER FOR INJECTION (100%)LIQUIDFalse1987-12-29BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
7ANDA089100_001discontinuedSTERILE WATER FOR INJECTION (100%)LIQUIDFalse1987-12-29BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
8ANDA206369_001RXSTERILE WATER FOR INJECTION (100%)LIQUIDFalseAP2015-09-02STERILE WATER FOR INJECTION
9NDA011525_001RXINDOCYANINE GREEN (25MG/VIAL)INJECTIONTrueAPIC-GREEN
10NDA011525_002discontinuedINDOCYANINE GREEN (50MG/VIAL)INJECTIONFalseIC-GREEN
11NDA011525_003discontinuedINDOCYANINE GREEN (10MG/VIAL)INJECTIONFalseIC-GREEN
12NDA011525_004discontinuedINDOCYANINE GREEN (40MG/VIAL)INJECTIONFalseIC-GREEN
13NDA018233_001RXSTERILE WATER FOR INJECTION (100%)LIQUIDTrueAPSTERILE WATER FOR INJECTION IN PLASTIC CONTAINER
14NDA018632_001RXSTERILE WATER FOR INJECTION (100%)LIQUIDTrueAP1982-06-30STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
15NDA018632_002RXSTERILE WATER FOR INJECTION (100%)LIQUIDTrueAP1988-04-19STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
16NDA018801_001RXSTERILE WATER FOR INJECTION (100%)LIQUIDTrueAP1982-10-27STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
17NDA018802_001RXSTERILE WATER FOR INJECTION (100%)LIQUIDTrueAP1982-10-27BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
18NDA019077_001discontinuedSTERILE WATER FOR INJECTION (100%)LIQUIDFalse1984-03-02STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
19NDA019633_001RXSTERILE WATER FOR INJECTION (100%)LIQUIDTrueAP1988-02-29STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
20NDA019869_001RXSTERILE WATER FOR INJECTION (100%)LIQUIDTrueAP1989-12-26STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
21NDA020444_001RXEPOPROSTENOL SODIUM (EQ 0.5MG BASE/VIAL)INJECTIONTrueAP1995-09-20FLOLAN
22NDA020444_002RXEPOPROSTENOL SODIUM (EQ 1.5MG BASE/VIAL)INJECTIONTrueAP1995-09-20FLOLAN
23NDA022260_001RXEPOPROSTENOL SODIUM (EQ 1.5MG BASE/VIAL)INJECTIONTrue2008-06-27VELETRI
24NDA022260_002RXEPOPROSTENOL SODIUM (EQ 0.5MG BASE/VIAL)INJECTIONFalse2012-06-28VELETRI

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p8318802 (view patent)2027-03-15NDA022260Epoprostenol Injectable Solution
2p8598227 (view patent)2027-02-02NDA022260Epoprostenol Injectable Solution

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
101174c59-da71-4470-badc-bbd76cb2b8db (view SPL)Sterile Water For Injection, USPprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2011-09-152647254887
2107a336c-9195-461b-f897-a920874284b3 (view SPL)Sterile Water for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2011-04-0110004097990
3210dc9ab-d6ca-4552-ac19-1be17792d290 (view SPL)Sterile Water For Injection, USP Pharmacy Bulk Package Not for Direct Infusion VIAFLEX Plastic ContainerprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-07-255003380013
421eadcab-0f74-4d3f-9bcc-6cf7e260fdd0 (view SPL)Bacteriostatic Water Injection, USP 30 mL Multi Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-02-172525840977
52afa9944-8b5d-4a41-bb39-c43412d82e10 (view SPL)Sterile Water For Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-05-151551542379
644d7a7d9-0e6e-4c79-aa87-11db6869790b (view SPL)BACTERIOSTATIC WATERfor Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-10-311493490739
747fc051c-b932-47a6-88d1-5a696ec8e07c (view SPL)BACTERIOSTATIC WATERfor Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-10-311493490739
856733651-d331-4e69-a6a3-303756ccc53c (view SPL)Epoprostenol Sodium for InjectionPrescribing InformationRx onlyprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2012-12-193007039258, 007031985, 007031995Epoprostenol Injectable Solution
96831bd7c-51c6-42fc-9f81-7febf6af4ee2 (view SPL)BACTERIOSTATIC WATERfor Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-101493490739
1078b35864-4bbc-4759-a5c1-7e4f25e22932 (view SPL)STERILE WATER FOR INJECTION, USP(pH 5.0-7.0)prescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE, STERILIZE2014-09-032005173005, 005173010, 005173020, 005173050
1178ef7ad3-451d-43d0-a9b6-5cf0aadca003 (view SPL)Sterile Water for Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE, PACK2015-07-206006416147
127d03bbfc-927f-4958-6bb4-be8864ddc35c (view SPL)STERILE WATER for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2012-04-0410004097990
138924e52e-8622-4ed6-a061-1908183e0a18 (view SPL)Sterile Water for Injection USPprescriptionHuman PrescriptionB. Braun Medical Inc.2014-09-122002647385
148bcf5572-49e1-4302-9522-56f57904cb4a (view SPL)Sterile Water for Injection, USP in VIAFLEX Plastic Container For Drug Diluent Use OnlyprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-07-254003380013
158fc8d87a-3951-4ac5-97df-c161ffc90475 (view SPL)Sterile Water for Injection USPprescriptionHuman PrescriptionB. Braun Medical Inc.2014-03-259002647850
16a6f24787-c243-445a-9c55-7c7479b292d9 (view SPL)Indocyanine Green for Injection USPprescriptionHuman PrescriptionDiagnostic Green GmbhMANUFACTURE2015-10-301701000424
17aa184016-e1fa-4326-b2a4-2e54c6caeac1 (view SPL)Sterile Water 5 mL Injection, USP Single Dose AmpuleprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-09-081525840027
18abc12e43-f4a2-4097-a1be-b24b4a20c04d (view SPL)BACTERIOSTATIC WATERfor Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-031521250661
19b3d23a29-6413-4fe0-96ec-858d15659aa2 (view SPL)Indocyanine Green for Injection USPprescriptionHuman PrescriptionPulsion Medical Systems SeMANUFACTURE2015-05-203254310424
20b77a85a8-dff3-40c5-aa4d-941aaf006e57 (view SPL)Sterile Water for Injection USP-Bacteriostatic Water for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-11-041633230249
21c6eed2ad-25f3-479e-9c28-1945eea88f8d (view SPL)Sterile Water For Injection, USP Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-01-123525840887
22c9bdc472-5489-45bf-b45b-9a3fafd0d291 (view SPL)STERILE WATER FOR INJECTION, USP(pH 5.0-7.0)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-061545692222
23ccadcf46-6a6f-436b-9bbc-17e2983a335f (view SPL)BACTERIOSTATIC WATERprescriptionHuman PrescriptionUs Medsource, Llcrepack2014-07-071616993977
24ce4113dc-1dc6-41d4-ba36-5c512667ba3c (view SPL)STERILE WATER FOR INJECTION, USP(pH 5.0-7.0)prescriptionHuman PrescriptionRemedyrepack Inc.2015-06-181617860349
25dd05b020-9be7-4aca-a1f4-4f57c0efb8ea (view SPL)STERILE WATERprescriptionHuman PrescriptionHospira, Inc.2013-12-041004091590
26fad47f9a-26d5-4a5e-4faa-2295e97033f6 (view SPL)Sterile Water for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-03-0614004097118

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII