Mannitol Injectable Solution

Brand(s)
Osmitrol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-03-19)
Oldest Current Product
1964-06-08
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\MANNITOL
FDAOB
INJECTION\INJECTION\MANNITOL\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\MANNITOL
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\MANNITOL

product(s) by strength(s)

mannitol 100 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004097713NDAHospira, Inc.1987-01-08MANNITOLINTRAVENOUSINJECTION, SOLUTIONNDA0196038ad3145e-00e7-4412-b9a5-06f00f264f30

mannitol 150 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004097714NDAHospira, Inc.1987-01-08MANNITOLINTRAVENOUSINJECTION, SOLUTIONNDA0196038ad3145e-00e7-4412-b9a5-06f00f264f30

mannitol 200 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002647578NDAB. Braun Medical Inc.1993-07-26MANNITOLINTRAVENOUSINJECTION, SOLUTIONNDA020006d12cc802-b538-4065-a264-f474ff3b3043
2003380357OsmitrolNDABaxter Healthcare Corporation1964-06-08MANNITOLINTRAVENOUSINJECTION, SOLUTIONNDA0136840d914965-7001-45cb-ba51-d7c5964b05bc

mannitol 250 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004094031NDAHospira, Inc.1967-12-22MANNITOLINTRAVENOUSINJECTION, SOLUTIONNDA0162698ad3145e-00e7-4412-b9a5-06f00f264f30

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005174050ANDAAmerican Regent, Inc.1990-09-30MANNITOLINTRAVENOUSINJECTION, SOLUTIONANDA08740974e9108e-8540-4442-82bc-4f46c6bdd334
2633230024ANDAApp Pharmaceuticals, Llc2000-03-19MANNITOLINTRAVENOUSINJECTION, SOLUTIONANDA0806778f5d51fd-7895-406a-a7cb-cca9762d8931, c395e13d-6ea1-4104-8b37-669cfb982f04

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840031NDAGeneral Injecatables & Vaccines, Inc2010-08-01MANNITOLINTRAVENOUSINJECTION, SOLUTION004094031NDA016269b8fd5c06-0f71-4699-8c5b-1a8868cb7da2
2551543192NDACardinal Health2010-02-01MANNITOLINTRAVENOUSINJECTION, SOLUTION004094031NDA016269bd8d7981-e238-458a-aef0-47cf76fc5816

mannitol 50 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004097712NDAHospira, Inc.1987-01-08MANNITOLINTRAVENOUSINJECTION, SOLUTIONNDA0196038ad3145e-00e7-4412-b9a5-06f00f264f30

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA080677MANNITOL 25%FRESENIUS KABI USA LLCANDA080677_001
2ANDA083051MANNITOL 25%INTERNATIONAL MEDICATION SYSTEMANDA083051_001
3ANDA086754MANNITOL 25%TrueABRAXIS PHARMACEUTICAL PRODUCTSANDA086754_001
4ANDA087409MANNITOL 25%LUITPOLD PHARMACEUTICALS INC1982-01-21ANDA087409_001
5ANDA087460MANNITOL 25%TrueWATSON LABORATORIES INC1983-06-27ANDA087460_001
6ANDA089239MANNITOL 25%TrueIGI LABORATORIES INC1987-05-06ANDA089239_001
7ANDA089240MANNITOL 25%TrueIGI LABORATORIES INC1987-05-06ANDA089240_001
8NDA005620MANNITOL 25%TrueMERCK AND CO INCNDA005620_001
9NDA013684OSMITROL 10% IN WATERBAXTER HEALTHCARE CORPNDA013684_001, NDA013684_002, NDA013684_003, NDA013684_004, NDA013684_005, NDA013684_006, NDA013684_007, NDA013684_008
10NDA014738MANNITOL 20%TrueB BRAUN MEDICAL INCNDA014738_001
11NDA016080MANNITOL 10%B BRAUN MEDICAL INCNDA016080_001, NDA016080_002, NDA016080_003, NDA016080_004, NDA016080_005, NDA016080_006, NDA016080_007
12NDA016269MANNITOL 10%HOSPIRA INCNDA016269_001, NDA016269_002, NDA016269_003, NDA016269_004, NDA016269_005, NDA016269_006
13NDA016472MANNITOL 10%TrueMILES LABORATORIES INCNDA016472_002, NDA016472_004, NDA016472_005
14NDA019603MANNITOL 10% IN PLASTIC CONTAINERHOSPIRA INC1987-01-08NDA019603_001, NDA019603_002, NDA019603_003, NDA019603_004
15NDA020006MANNITOL 10% IN PLASTIC CONTAINERB BRAUN MEDICAL INC1993-07-26NDA020006_001, NDA020006_002, NDA020006_003, NDA020006_004

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA080677_001RXMANNITOL (12.5GM/50ML)INJECTIONFalseAPMANNITOL 25%
2ANDA083051_001RXMANNITOL (12.5GM/50ML)INJECTIONFalseAPMANNITOL 25%
3ANDA086754_001discontinuedMANNITOL (12.5GM/50ML)INJECTIONFalseMANNITOL 25%
4ANDA087409_001RXMANNITOL (12.5GM/50ML)INJECTIONFalseAP1982-01-21MANNITOL 25%
5ANDA087460_001discontinuedMANNITOL (12.5GM/50ML)INJECTIONFalse1983-06-27MANNITOL 25%
6ANDA089239_001discontinuedMANNITOL (12.5GM/50ML)INJECTIONFalse1987-05-06MANNITOL 25%
7ANDA089240_001discontinuedMANNITOL (12.5GM/50ML)INJECTIONFalse1987-05-06MANNITOL 25%
8NDA005620_001discontinuedMANNITOL (12.5GM/50ML)INJECTIONFalseMANNITOL 25%
9NDA013684_001RXMANNITOL (5GM/100ML)INJECTIONFalseAPOSMITROL 10% IN WATER
10NDA013684_002RXMANNITOL (10GM/100ML)INJECTIONFalseAPOSMITROL 10% IN WATER
11NDA013684_003RXMANNITOL (20GM/100ML)INJECTIONFalseAPOSMITROL 10% IN WATER
12NDA013684_004RXMANNITOL (15GM/100ML)INJECTIONFalseAPOSMITROL 10% IN WATER
13NDA013684_005RXMANNITOL (5GM/100ML)INJECTIONFalseAPOSMITROL 10% IN WATER
14NDA013684_006RXMANNITOL (10GM/100ML)INJECTIONFalseAPOSMITROL 10% IN WATER
15NDA013684_007RXMANNITOL (20GM/100ML)INJECTIONFalseAPOSMITROL 10% IN WATER
16NDA013684_008RXMANNITOL (15GM/100ML)INJECTIONFalseAPOSMITROL 10% IN WATER
17NDA014738_001discontinuedMANNITOL (20GM/100ML)INJECTIONFalseMANNITOL 20%
18NDA016080_001RXMANNITOL (5GM/100ML)INJECTIONFalseAPMANNITOL 10%
19NDA016080_002RXMANNITOL (10GM/100ML)INJECTIONFalseAPMANNITOL 10%
20NDA016080_003RXMANNITOL (15GM/100ML)INJECTIONFalseAPMANNITOL 10%
21NDA016080_004RXMANNITOL (20GM/100ML)INJECTIONFalseAPMANNITOL 10%
22NDA016080_005RXMANNITOL (15GM/100ML)INJECTIONFalseAPMANNITOL 10%
23NDA016080_006RXMANNITOL (10GM/100ML)INJECTIONFalseAPMANNITOL 10%
24NDA016080_007RXMANNITOL (5GM/100ML)INJECTIONFalseAPMANNITOL 10%
25NDA016269_001discontinuedMANNITOL (5GM/100ML)INJECTIONFalseMANNITOL 10%
26NDA016269_002discontinuedMANNITOL (10GM/100ML)INJECTIONFalseMANNITOL 10%
27NDA016269_003discontinuedMANNITOL (15GM/100ML)INJECTIONFalseMANNITOL 10%
28NDA016269_004discontinuedMANNITOL (20GM/100ML)INJECTIONFalseMANNITOL 10%
29NDA016269_005discontinuedMANNITOL (12.5GM/50ML)INJECTIONFalseMANNITOL 10%
30NDA016269_006RXMANNITOL (12.5GM/50ML)INJECTIONFalseAP1994-08-25MANNITOL 10%
31NDA016472_002discontinuedMANNITOL (10GM/100ML)INJECTIONFalseMANNITOL 10%
32NDA016472_004discontinuedMANNITOL (20GM/100ML)INJECTIONFalseMANNITOL 10%
33NDA016472_005discontinuedMANNITOL (15GM/100ML)INJECTIONFalseMANNITOL 10%
34NDA019603_001RXMANNITOL (5GM/100ML)INJECTIONFalseAP1987-01-08MANNITOL 10% IN PLASTIC CONTAINER
35NDA019603_002RXMANNITOL (10GM/100ML)INJECTIONFalseAP1987-01-08MANNITOL 10% IN PLASTIC CONTAINER
36NDA019603_003RXMANNITOL (15GM/100ML)INJECTIONFalseAP1990-01-08MANNITOL 10% IN PLASTIC CONTAINER
37NDA019603_004RXMANNITOL (20GM/100ML)INJECTIONFalseAP1990-01-08MANNITOL 10% IN PLASTIC CONTAINER
38NDA020006_001RXMANNITOL (5GM/100ML)INJECTIONFalseAP1993-07-26MANNITOL 10% IN PLASTIC CONTAINER
39NDA020006_002RXMANNITOL (10GM/100ML)INJECTIONFalseAP1993-07-26MANNITOL 10% IN PLASTIC CONTAINER
40NDA020006_003RXMANNITOL (15GM/100ML)INJECTIONFalseAP1993-07-26MANNITOL 10% IN PLASTIC CONTAINER
41NDA020006_004RXMANNITOL (20GM/100ML)INJECTIONFalseAP1993-07-26MANNITOL 10% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10d914965-7001-45cb-ba51-d7c5964b05bc (view SPL)OSMITROL Injection (Mannitol Injection, USP) in VIAFLEX Plastic Container For Therapeutic Use OnlyprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2009-09-115003380357, 003380351, 003380353, 003380355
274e9108e-8540-4442-82bc-4f46c6bdd334 (view SPL)MANNITOL INJECTION, USP 25% CONCENTRATIONprescriptionHuman PrescriptionAmerican Regent, Inc.LABEL, MANUFACTURE, PACK, STERILIZE2011-10-072005174050
38ad3145e-00e7-4412-b9a5-06f00f264f30 (view SPL)Mannitol I.V.Mannitol Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-03-1912004094031, 004097712, 004097713, 004097714, 004097715
48f5d51fd-7895-406a-a7cb-cca9762d8931 (view SPL)Mannitol Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-02-181633230024
5b8fd5c06-0f71-4699-8c5b-1a8868cb7da2 (view SPL)25% Mannitol 250 mg/mL Injection, USP 50 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-06-213525840031
6bd8d7981-e238-458a-aef0-47cf76fc5816 (view SPL)Mannitol I.V.Mannitol Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-081551543192
7c395e13d-6ea1-4104-8b37-669cfb982f04 (view SPL)Mannitol Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-08-312633230024
8d12cc802-b538-4065-a264-f474ff3b3043 (view SPL)20% Mannitol Injection USPprescriptionHuman PrescriptionB. Braun Medical Inc.2014-03-256002647578

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