Soybean Oil Injectable Suspension

Brand(s)
Nutrilipid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
B. Braun Medical Inc. (2014-08-25)
Oldest Current Product
2014-06-30
License(s)
NDA
RxNORM
INJECTABLE SUSPENSION\SOYBEAN OIL
FDAOB
INJECTION\INJECTION\SOYBEAN OIL\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\SOYBEAN OIL
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\SOYBEAN OIL

product(s) by strength(s)

soybean oil 200 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002644460NutrilipidNDAB. Braun Medical Inc.2014-06-30SOYBEAN OILINTRAVENOUSINJECTION, SOLUTIONNDA019531193290b1-a0a1-4054-a22a-de5c9e7a8b73

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1NDA017643INTRALIPID 10%FRESENIUS KABI DEUTSCHLAND GMBHNDA017643_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
2NDA018449INTRALIPID 20%FRESENIUS KABI DEUTSCHLAND GMBHNDA018449_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
3NDA018465SOYACAL 10%TrueALPHA THERAPEUTIC CORP1983-06-29NDA018465_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
4NDA018660TRAVAMULSION 10%TrueBAXTER HEALTHCARE CORP1982-02-26NDA018660_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
5NDA018758TRAVAMULSION 20%TrueBAXTER HEALTHCARE CORP1983-02-15NDA018758_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
6NDA018786SOYACAL 20%TrueALPHA THERAPEUTIC CORP1983-06-29NDA018786_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
7NDA018969LIPOSYN III 10%TrueHOSPIRA INC1984-09-24NDA018969_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
8NDA018970LIPOSYN III 20%TrueHOSPIRA INC1984-09-25NDA018970_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
9NDA019531NUTRILIPID 10%B BRAUN MEDICAL INC1993-05-28NDA019531_001, NDA019531_002EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
10NDA019942INTRALIPID 30%FRESENIUS KABI DEUTSCHLAND GMBH1993-12-30NDA019942_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
11NDA020181LIPOSYN III 30%TrueHOSPIRA INC1998-01-13NDA020181_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension
12NDA020248INTRALIPID 20%FRESENIUS KABI DEUTSCHLAND GMBH1996-08-07NDA020248_001EGG YOLK PHOSPHOLIPIDS / Glycerin / Soybean Oil Injectable Suspension

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1NDA017643_001RXSOYBEAN OIL (10%)INJECTIONTrueAPINTRALIPID 10%
2NDA018449_001RXSOYBEAN OIL (20%)INJECTIONTrueAPINTRALIPID 20%
3NDA018465_001discontinuedSOYBEAN OIL (10%)INJECTIONFalse1983-06-29SOYACAL 10%
4NDA018660_001discontinuedSOYBEAN OIL (10%)INJECTIONFalse1982-02-26TRAVAMULSION 10%
5NDA018758_001discontinuedSOYBEAN OIL (20%)INJECTIONFalse1983-02-15TRAVAMULSION 20%
6NDA018786_001discontinuedSOYBEAN OIL (20%)INJECTIONFalse1983-06-29SOYACAL 20%
7NDA018969_001discontinuedSOYBEAN OIL (10%)INJECTIONFalse1984-09-24LIPOSYN III 10%
8NDA018970_001discontinuedSOYBEAN OIL (20%)INJECTIONFalse1984-09-25LIPOSYN III 20%
9NDA019531_001RXSOYBEAN OIL (10%)INJECTIONTrueAP1993-05-28NUTRILIPID 10%
10NDA019531_002RXSOYBEAN OIL (20%)INJECTIONTrueAP1993-05-28NUTRILIPID 10%
11NDA019942_001RXSOYBEAN OIL (30%)INJECTIONTrueAP1993-12-30INTRALIPID 30%
12NDA020181_001discontinuedSOYBEAN OIL (30%)INJECTIONFalse1998-01-13LIPOSYN III 30%
13NDA020248_001RXSOYBEAN OIL (20%)INJECTIONTrueAP1996-08-07INTRALIPID 20%

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1193290b1-a0a1-4054-a22a-de5c9e7a8b73 (view SPL)These highlights do not include all the information needed to use NUTRILIPID 20% safely and effectively. See full prescribing information for NUTRILIPID 20%. NUTRILIPID (lipid injectable emulsion) , for intravenous use Initial U.S. Approval: 1975prescriptionHuman PrescriptionB. Braun Medical Inc.2014-08-259002644460

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