Mannitol / Sorbitol Irrigation Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-03-11)
Oldest Current Product
1980-02-22
License(s)
NDA
RxNORM
IRRIGATION SOLUTION\MANNITOL:SORBITOL
FDAOB
IRRIGATION\SOLUTION\MANNITOL: SORBITOL
SPL Active
URETHRAL\IRRIGANT\MANNITOL: SORBITOL
SPL Moiety
URETHRAL\IRRIGANT\MANNITOL: SORBITOL

product(s) by strength(s)

mannitol 5.4 mg/ml / sorbitol 27 mg/ml irrigation solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004097981NDAHospira, Inc.1980-02-22MANNITOL, SORBITOLURETHRALIRRIGANTNDA018316672d4453-9dd5-4577-a38f-c15b7f33e9fb

application(s)

#idtitledeprecatedapplicantapproved drug
1ANDA080224SORBITOL-MANNITOLTrueHOSPIRA INCANDA080224_001
2NDA017636SORBITOL-MANNITOL IN PLASTIC CONTAINERTrueHOSPIRA INCNDA017636_001
3NDA018316SORBITOL-MANNITOL IN PLASTIC CONTAINERHOSPIRA INCNDA018316_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1ANDA080224_001discontinuedSORBITOL (2.7GM/100ML), MANNITOL (540MG/100ML)IRRIGATIONSOLUTIONFalseSORBITOL-MANNITOL
2NDA017636_001discontinuedSORBITOL (2.7GM/100ML), MANNITOL (540MG/100ML)IRRIGATIONSOLUTIONFalseSORBITOL-MANNITOL IN PLASTIC CONTAINER
3NDA018316_001RXSORBITOL (2.7GM/100ML), MANNITOL (540MG/100ML)IRRIGATIONSOLUTIONFalseSORBITOL-MANNITOL IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1672d4453-9dd5-4577-a38f-c15b7f33e9fb (view SPL)SORBITOL-MANNITOL IRRIGATIONprescriptionHuman PrescriptionHospira, Inc.2014-03-1112004097981

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