hydroxyethyl starch 130-0.4 Injectable Solution

Brand(s)
Voluven
Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2010-06-25
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\HYDROXYETHYL STARCH 130-0.4
FDAOB
INJECTION\INJECTION\DOPAMINE HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\HYDROXYETHYL STARCH 130/0.4
INTRAVENOUS\INJECTION, SOLUTION\HYDROXYETHYL STARCH 130/0.4: SODIUM CHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\CHLORIDE ION: HYDROXYETHYL STARCH 130/0.4
INTRAVENOUS\INJECTION, SOLUTION\HYDROXYETHYL STARCH 130/0.4

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002641968ANDAB. Braun Medical Inc.2015-01-09HYDROXYETHYL STARCH 130/0.4, SODIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA110013be7729c9-f7cf-483b-bafe-0d42d6b62f06
2004091029VoluvenANDAHospira, Inc.2010-06-25HYDROXYETHYL STARCH 130/0.4INTRAVENOUSINJECTION, SOLUTIONANDA070012c2c45e02-5d9a-4a54-f291-e5b54671b08b

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070011DOPAMINE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1985-08-29ANDA070011_001Dopamine Injectable Solution
2ANDA070012DOPAMINE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1985-06-12ANDA070012_001Dopamine Injectable Solution
3ANDA070013DOPAMINE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1985-06-12ANDA070013_001Dopamine Injectable Solution
4ANDA070046DOPAMINE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1985-08-29ANDA070046_001Dopamine Injectable Solution
5ANDA070047DOPAMINE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1985-08-29ANDA070047_001Dopamine Injectable Solution
6ANDA070058DOPAMINE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1985-03-20ANDA070058_001Dopamine Injectable Solution
7ANDA070059DOPAMINE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1985-03-20ANDA070059_001Dopamine Injectable Solution
8ANDA070087DOPAMINE HYDROCHLORIDETrueIGI LABORATORIES INC1985-10-23ANDA070087_001Dopamine Injectable Solution
9ANDA070089DOPAMINE HYDROCHLORIDETrueIGI LABORATORIES INC1985-10-23ANDA070089_001Dopamine Injectable Solution
10ANDA070090DOPAMINE HYDROCHLORIDETrueIGI LABORATORIES INC1985-10-23ANDA070090_001Dopamine Injectable Solution
11ANDA070091DOPAMINE HYDROCHLORIDETrueIGI LABORATORIES INC1985-10-23ANDA070091_001Dopamine Injectable Solution
12ANDA070092DOPAMINE HYDROCHLORIDETrueIGI LABORATORIES INC1985-10-23ANDA070092_001Dopamine Injectable Solution
13ANDA070093DOPAMINE HYDROCHLORIDETrueIGI LABORATORIES INC1985-10-23ANDA070093_001Dopamine Injectable Solution
14ANDA070094DOPAMINE HYDROCHLORIDETrueIGI LABORATORIES INC1985-10-23ANDA070094_001Dopamine Injectable Solution
15ANDA070364DOPAMINE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1985-12-04ANDA070364_001Dopamine Injectable Solution
16ANDA070558DOPAMINE HYDROCHLORIDETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1985-09-20ANDA070558_001Dopamine Injectable Solution
17ANDA070559DOPAMINE HYDROCHLORIDETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1985-09-20ANDA070559_001Dopamine Injectable Solution
18ANDA070656DOPAMINE HYDROCHLORIDETrueABBOTT LABORATORIES HOSP PRODUCTS DIV1989-01-24ANDA070656_001Dopamine Injectable Solution
19ANDA070657DOPAMINE HYDROCHLORIDETrueABBOTT LABORATORIES HOSP PRODUCTS DIV1989-01-24ANDA070657_001Dopamine Injectable Solution
20ANDA070799DOPAMINE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC1987-02-11ANDA070799_001Dopamine Injectable Solution
21ANDA070820DOPAMINE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC1987-02-11ANDA070820_001Dopamine Injectable Solution
22ANDA070826DOPAMINE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC1987-02-11ANDA070826_001Dopamine Injectable Solution
23ANDA072999DOPAMINE HYDROCHLORIDETrueTEVA PARENTERAL MEDICINES INC1991-10-23ANDA072999_001Dopamine Injectable Solution
24ANDA073000DOPAMINE HYDROCHLORIDETrueTEVA PARENTERAL MEDICINES INC1991-10-23ANDA073000_001Dopamine Injectable Solution
25ANDA074403DOPAMINE HYDROCHLORIDETrueHOSPIRA INC1996-05-23ANDA074403_001Dopamine Injectable Solution
26NDA017395INTROPINTrueHOSPIRA INCNDA017395_001, NDA017395_002, NDA017395_003Dopamine Injectable Solution
27NDA018014DOPAMINE HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEMNDA018014_001Dopamine Injectable Solution
28NDA018132DOPAMINE HYDROCHLORIDEHOSPIRA INCNDA018132_001, NDA018132_002, NDA018132_003, NDA018132_004Dopamine Injectable Solution
29NDA018138DOPAMINE HYDROCHLORIDETrueWARNER CHILCOTT DIV WARNER LAMBERT CONDA018138_001Dopamine Injectable Solution
30NDA018398DOPAMINE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARENDA018398_001, NDA018398_002Dopamine Injectable Solution
31NDA018549DOPAMINE HYDROCHLORIDETrueLYPHOMED DIV FUJISAWA USA INC1983-03-11NDA018549_001Dopamine Injectable Solution
32NDA018656DOPAMINE HYDROCHLORIDETrueIGI LABORATORIES INC1983-06-28NDA018656_001Dopamine Injectable Solution
33NDA018826DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERHOSPIRA INC1983-09-30NDA018826_001, NDA018826_002, NDA018826_003Dopamine Injectable Solution
34NDA019099DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%B BRAUN MEDICAL INC1986-10-15NDA019099_001, NDA019099_002, NDA019099_003, NDA019099_004Dopamine Injectable Solution
35NDA019615DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1987-03-27NDA019615_001, NDA019615_002, NDA019615_003, NDA019615_004Dopamine Injectable Solution
36NDA020542DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%TrueHOSPIRA INC1995-08-30NDA020542_001Dopamine Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070011_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1985-08-29DOPAMINE HYDROCHLORIDE
2ANDA070012_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1985-06-12DOPAMINE HYDROCHLORIDE
3ANDA070013_001discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalse1985-06-12DOPAMINE HYDROCHLORIDE
4ANDA070046_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1985-08-29DOPAMINE HYDROCHLORIDE
5ANDA070047_001discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalse1985-08-29DOPAMINE HYDROCHLORIDE
6ANDA070058_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1985-03-20DOPAMINE HYDROCHLORIDE
7ANDA070059_001discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalse1985-03-20DOPAMINE HYDROCHLORIDE
8ANDA070087_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1985-10-23DOPAMINE HYDROCHLORIDE
9ANDA070089_001discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalse1985-10-23DOPAMINE HYDROCHLORIDE
10ANDA070090_001discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalse1985-10-23DOPAMINE HYDROCHLORIDE
11ANDA070091_001discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalse1985-10-23DOPAMINE HYDROCHLORIDE
12ANDA070092_001discontinuedDOPAMINE HYDROCHLORIDE (160MG/ML)INJECTIONFalse1985-10-23DOPAMINE HYDROCHLORIDE
13ANDA070093_001discontinuedDOPAMINE HYDROCHLORIDE (160MG/ML)INJECTIONFalse1985-10-23DOPAMINE HYDROCHLORIDE
14ANDA070094_001discontinuedDOPAMINE HYDROCHLORIDE (160MG/ML)INJECTIONFalse1985-10-23DOPAMINE HYDROCHLORIDE
15ANDA070364_001discontinuedDOPAMINE HYDROCHLORIDE (160MG/ML)INJECTIONFalse1985-12-04DOPAMINE HYDROCHLORIDE
16ANDA070558_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1985-09-20DOPAMINE HYDROCHLORIDE
17ANDA070559_001discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalse1985-09-20DOPAMINE HYDROCHLORIDE
18ANDA070656_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1989-01-24DOPAMINE HYDROCHLORIDE
19ANDA070657_001discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalse1989-01-24DOPAMINE HYDROCHLORIDE
20ANDA070799_001RXDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONTrueAP1987-02-11DOPAMINE HYDROCHLORIDE
21ANDA070820_001RXDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONTrueAP1987-02-11DOPAMINE HYDROCHLORIDE
22ANDA070826_001RXDOPAMINE HYDROCHLORIDE (160MG/ML)INJECTIONTrueAP1987-02-11DOPAMINE HYDROCHLORIDE
23ANDA072999_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1991-10-23DOPAMINE HYDROCHLORIDE
24ANDA073000_001discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalse1991-10-23DOPAMINE HYDROCHLORIDE
25ANDA074403_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1996-05-23DOPAMINE HYDROCHLORIDE
26NDA017395_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalseINTROPIN
27NDA017395_002discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalseINTROPIN
28NDA017395_003discontinuedDOPAMINE HYDROCHLORIDE (160MG/ML)INJECTIONFalseINTROPIN
29NDA018014_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalseDOPAMINE HYDROCHLORIDE
30NDA018132_001RXDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONTrueAPDOPAMINE HYDROCHLORIDE
31NDA018132_002RXDOPAMINE HYDROCHLORIDE (80MG/100ML)INJECTIONTrueAP1982-02-04DOPAMINE HYDROCHLORIDE
32NDA018132_003RXDOPAMINE HYDROCHLORIDE (160MG/100ML)INJECTIONTrueAP1982-02-04DOPAMINE HYDROCHLORIDE
33NDA018132_004RXDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONTrueAP1982-07-09DOPAMINE HYDROCHLORIDE
34NDA018138_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalseDOPAMINE HYDROCHLORIDE
35NDA018398_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalseDOPAMINE HYDROCHLORIDE
36NDA018398_002discontinuedDOPAMINE HYDROCHLORIDE (80MG/ML)INJECTIONFalse1982-03-22DOPAMINE HYDROCHLORIDE
37NDA018549_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1983-03-11DOPAMINE HYDROCHLORIDE
38NDA018656_001discontinuedDOPAMINE HYDROCHLORIDE (40MG/ML)INJECTIONFalse1983-06-28DOPAMINE HYDROCHLORIDE
39NDA018826_001RXDOPAMINE HYDROCHLORIDE (80MG/100ML)INJECTIONTrueAP1983-09-30DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
40NDA018826_002RXDOPAMINE HYDROCHLORIDE (160MG/100ML)INJECTIONTrueAP1983-09-30DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
41NDA018826_003RXDOPAMINE HYDROCHLORIDE (320MG/100ML)INJECTIONTrueAP1983-09-30DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
42NDA019099_001RXDOPAMINE HYDROCHLORIDE (40MG/100ML)INJECTIONTrue1986-10-15DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
43NDA019099_002RXDOPAMINE HYDROCHLORIDE (80MG/100ML)INJECTIONTrueAP1986-10-15DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
44NDA019099_003RXDOPAMINE HYDROCHLORIDE (160MG/100ML)INJECTIONTrueAP1986-10-15DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
45NDA019099_004RXDOPAMINE HYDROCHLORIDE (320MG/100ML)INJECTIONTrueAP1986-10-15DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
46NDA019615_001RXDOPAMINE HYDROCHLORIDE (80MG/100ML)INJECTIONTrueAP1987-03-27DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
47NDA019615_002RXDOPAMINE HYDROCHLORIDE (160MG/100ML)INJECTIONTrueAP1987-03-27DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
48NDA019615_003RXDOPAMINE HYDROCHLORIDE (320MG/100ML)INJECTIONTrueAP1987-03-27DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
49NDA019615_004RXDOPAMINE HYDROCHLORIDE (640MG/100ML)INJECTIONTrue1987-03-27DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
50NDA020542_001discontinuedDOPAMINE HYDROCHLORIDE (1.6MG/ML)INJECTIONFalse1995-08-30DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1be7729c9-f7cf-483b-bafe-0d42d6b62f06 (view SPL)These highlights do not include all the information needed to use6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection safely and effectively. See full prescribing information for 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection . 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection For administration by intravenous infusion Initial U.S. Approval: 2007prescriptionHuman PrescriptionB. Braun Medical Inc.2015-01-087002641968
2c2c45e02-5d9a-4a54-f291-e5b54671b08b (view SPL)These highlights do not include all the information needed to use Voluvensafely and effectively. See full prescribing information for Voluven. VOLUVEN(6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection), for administration by intravenous infusionInitial U.S. Approval: 2007prescriptionHuman PrescriptionHospira, Inc.ANALYSIS, MANUFACTURE2015-02-2721004091029

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